PENTAX OF-B113Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04961333084050), received between Jul 9, 2021 and Jan 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K131902); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2023Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  PER THE INITIAL REPORT, ANOTHER OF-B113 DETACHED THIS MORNING. IN THE ENDO ROOM #2 WITH DRE LAROUCHE, THE TUBING WENT OUT OF THE BLACK CONNECTOR. PRODUCT DID DETACH DURING AN EMR PROCEDURE WITH BLEEDING. HOWEVER, ANOTHER OF-B113 WAS USED TO COMPLETE THE PROCEDURE. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200167 ↗
• MalfunctionJul 24, 2021Break; Break

  THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THE OF-B113 IRRIGATION TUBES BURST DURING THE EXAMINATION OR DURING MANUAL CLEANING WITH LUER LOCK SYRINGES. A LARGE ""BUBBLE"" FORMS. THE STAFF STATE THAT RECENTLY THE TUBES REGULARLY BURST DURING USE AND CLEANING. VERY ANNOYING BECAUSE THIS ALSO HAPPENS DURING THE ENDOSCOPY EXAMINATIONS!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222398 ↗
• MalfunctionJul 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. WHILE WORKING IN THE ENDOSCOPY ROOM WITH DOCTOR, THE OF-B113 BLEW OFF THE IRRIGATION TUBING (METAL LURE LOCK ATTACHMENT DISCONNECTED FROM TUBING). THIS RESULTED IN WATER SPILLING ALL OVER THE ROOM. THE OF-B113 BROKE AT THE METAL END THAT ATTACHED TO THE IRRIGATION TUBING VIA A LURE LOCK. DESCRIPTION OF ANY ACTIONS TAKEN: WE SWITCHED OUT THE OF-B113 THREE TIMES. IT OCCURRED WITH ALL THE OF-B113 PIECES. WE HAD TO TURN THE IRRIGATION RIGHT DOWN TO 1 OR 2 AND STILL HAD TO HOLD THE OF-B113 TOGETHER. I ALSO FOLLOWED THE OF-B113 FROM ROOM THROUGH THE REPROCESSING PROCEDURE: OF-B11 GETS DISCONNECTS FROM SCOPE, WASHED IN THE SINK, THEN ATTACHED BACK TO THE SCOPE, FLUSHED USING THE SCOPE BUDDY AND THEN PUT INTO THE MEDIATOR. THE TUBING REMAINS CONNECTED TO THE SCOPE AND FLUSHED DURING THE HLD PROCESS. AFTER HLD, THEY DISCONNECT THE OF-B113 FROM THE SCOPE, DRY IT AND LEAVE IT TO HANG TO DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194412 ↗
• MalfunctionJul 9, 2021Blocked Connection; Blocked Connection

  THE SCREW PITCH OF 3RD PARTY IRRIGATION TUBING HAS AN OVER PLASTIC THAT MAKES IT DIFFICULT TO UNSCREWING THE TUBING OF-B113. IT IS NECESSARY TO REPLACE THE THREE BOXES PURCHASED BY OUR CUSTOMER BY ANOTHER BATCH. THIS EVENT OCCURRED AT THE TIME OF AFTER USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140742 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131902. One submission often covers many models, so check the product and lot details in each record.

• Z-0318-2017 · Aug 15, 2016 · Terminated
  Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forcep
• Z-2071-2016 · Apr 6, 2016 · Terminated
  Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti