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

Model Number WA53005A

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It was reported the scope light guide adapter was broken.The issue found during maintenance.There was no patient involvement on this reported event.No harm reported.No user injury reported due to the event.

Manufacturer Narrative

Communication with the customer noted that there was no procedure involved.Telescope was not used.Telescope was not reprocessed at the time of return.Broken lg adapter was also confirmed/inspected by the field service engineer (fse).The subject device was received and evaluated.The reported issue was confirmed.Device evaluation found the lg adaptor was damaged, image cannot be checked.Investigation is ongoing.This report will be supplemented accordingly following 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, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: TELESCOPE,HD, QUICK LOCK, AUTOCLAVABLE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16948067
• MDR Text Key: 315532557
• Report Number: 9610773-2023-01352
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K950076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: 805943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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