MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 12°, LONG; AUTOCLAVABLE TELESCOPE

Model Number WA20021A

Device Problems Crack (1135); Poor Quality Image (1408)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Olympus was informed by the sterile processing technician that the customer rigid autoclavable telescope, long ¿looks like the lens is cracked when looking through it¿.The customer reported problem was found at reprocessing.No death or injury and no impact to person or other was reported to olympus.

Manufacturer Narrative

The referenced device was returned to the olympus repair center.The repair inspection confirmed the customer¿s reported issue, broken lens inside the optical system was identified attributing to a blurry/foggy image.No moisture in the optical system was observed.The inspection also noted the rigid outer tube is bent.The investigation is in progress.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Manufacturer Narrative

This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.Although a definitive root cause of the defects could not be identified, it was determined that the broken lens was likely caused by excessive force during use by the customer.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: TELESCOPE, 4 MM, 12°, LONG
• Type of Device: AUTOCLAVABLE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16100269
• MDR Text Key: 307678534
• Report Number: 9610773-2023-00090
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761051422
• UDI-Public: 04042761051422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA20021A
• Device Catalogue Number: WA20021A
• Device Lot Number: 800471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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