MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number A4674A

Device Problems Material Twisted/Bent (2981); Optical Problem (3001)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation found that the defect was shown to be caused by the customer¿s mishandling.There are no additional reportable malfunctions.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the rigid endoscope telescope was slightly bent and had a defective optic.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The event likely occurred due to excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
• Type of Device: RIGID ENDOSCOPE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18886218
• MDR Text Key: 337802637
• Report Number: 9610773-2024-00684
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761006361
• UDI-Public: 04042761006361
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K904939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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: A4674A
• Device Lot Number: 800284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2019
• 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