MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH IRRIGATION PORT, 2 STOPCOCKS, ROTATABLE; ACCESSORIE FOR RESECTOSCOPE, RIGID

Model Number	A22053A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's allegation was confirmed.The device evaluation found that the locking ring of the item was broken.Based on the results of the investigation, it is likely that the following led to the malfunction: wear and tear/insufficient maintenance.A device history review revealed no issues that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the irrigation port had broken plastic at coupling.The issue was found after an unspecified operation.The procedure was completed with the same device.There were no reports of any delay.There were no reports of patient or user harm associated with this event.

• Brand Name: IRRIGATION PORT, 2 STOPCOCKS, ROTATABLE
• Common Device Name: ACCESSORIE FOR RESECTOSCOPE, RIGID
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19111431
• Report Number: 9610773-2024-01024
• Device Sequence Number: 8283502
• Product Code: HIH
• UDI-Device Identifier: 04042761021043
• UDI-Public: 04042761021043
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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: A22053A
• Device Lot Number: 22501-0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown