WASHINGTON, D.C. — The U.S. Food and Drug Administration, or FDA for short, issued a warning letter to Lymol Medical Corporation, which is a medical device manufacturer, due to the firm’s failure to investigate complaints concerning its rigid bronchoscope. According to an article published by raps.org, the FDA sent a warning letter in early April demanding that the company immediately correct problems associated with cleaning, sterilizing, and storing its Rigid Bronchoscope System as well as its Medical Optical Telescope. The medical device manufacturer received complaints that its Rigid Bronchoscope uncoupled while in use, which could inflict a catastrophic injury or kill the patient. Additionally, an O-ring separated during sterilization. Both of these defects could lead to severe injury to the patient.
The FDA’s warning letter to Lymol establishes the medical device manufacturer’s disregard for the safety of its products. The strongly-worded letter also demonstrates that Lymol failed to comply with critical FDA requirements concerning reporting and testing of the medical devices it produced.
The problems surfaced during an inspection of Lymol in February of 2020. An inspector for the FDA determined that Lymol did not validate its manual cleaning, storage conditions, or sterilization procedures for its Rigid Bronchoscope or Optical Telescope. Inspectors learned that Lymol altered the design of the telescope and bronchoscope so the two pieces would not become stuck. The FDA found that the company never validated the procedure. Validation is necessary for medical device production to prove the safety and efficacy of the device.
More egregiously, the company received complaints that its bronchoscope uncoupled during use, which could severely harm the patient. Despite learning of this potentially deadly defect, the company refused to follow established procedures to document and report the defects. The medical device manufacturer failed to address the complaints it received and refused to complete the necessary reports. In one instance, the FDA inspectors determined that one of the reports files by Lymol was erroneous.
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