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

Model Number A22053A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 340903765
• Report Number: 9610773-2024-01024
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761021043
• UDI-Public: 04042761021043
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1