MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE

Model Number WA53005A

Device Problem Break (1069)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the telescope, 10 mm, 30°, hd, quick lock had a cloudy lens, and the lower left corner of the screen is hard to see.The issue was found during inspection for use for a therapeutic, laparoscopic colectomy procedure.The procedure was completed with a similar device.Inspection and testing of the returned device found cover glass damage.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation.The device evaluation found cover glass damage, image failure, and misalignment of the objective lens.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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, it is likely that the event occurred due to user error, improper handling, and application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16659582
• MDR Text Key: 312519217
• Report Number: 9610773-2023-00938
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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: WA53005A
• Device Catalogue Number: WA53005A
• Device Lot Number: 507096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2005
• 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