PENTAX BS-LL1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333227259), received between Jul 31, 2021 and Jul 31, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Disconnect” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K951199); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2021Failure to Disconnect; Failure to Disconnect

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. THE FIBER SCOPE CAN'T EMIT THE LIGHT. BS-LL1 CAN'T IGNITE THE LIGHT AND IT SHOWED NO BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951199. One submission often covers many models, so check the product and lot details in each record.

• Z-2065-2016 · Apr 6, 2016 · Terminated
  Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tiss
• Z-2076-2016 · Apr 6, 2016 · Terminated
  Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to org