MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, 4 MM; RESECTOSCOPE

Model Number A22002A

Device Problems Break (1069); Component Missing (2306)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device evaluation found a broken/ missing eyepiece.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer returned the telescope, to olympus repair center for evaluation of a reported eyepiece that broke off completely.The issue was found during reprocessing.The surgery was completed.No patient injury or harm has been reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the eyepiece damage occurred due to user error, improper handling and application of excessive force.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 30°, 4 MM
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17007698
• MDR Text Key: 316029452
• Report Number: 9610773-2023-01436
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020855
• UDI-Public: 04042761020855
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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: A22002A
• Device Catalogue Number: A22002A
• Device Lot Number: 592234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2011
• 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