MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; TUBE,IRRIGATION FOR 30/40 SERIES

Model Number	OF-B113
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event is unavailable.Evaluation summary: it was caused due to an excessive force applied on the metal luer lock attachment on the tube.It was non-repair item so that it was replaced with new one.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
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.

• Brand Name: PENTAX
• Common Device Name: TUBE,IRRIGATION FOR 30/40 SERIES
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12194412
• Report Number: 9610877-2021-10439
• Device Sequence Number: 1480534
• Product Code: FDF
• UDI-Device Identifier: 04961333084050
• UDI-Public: 04961333084050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OF-B113
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1