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

Model Number WA20021A

Device Problems Break (1069); No Display/Image (1183)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the olympus service center.The service inspection confirmed the customer¿s reported issue, broken lens inside the optical system attributing to a blurry image.No moisture was observed inside the optical system.The investigation is still 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.

Event Description

Olympus was informed via repair request that the customer autoclavable telescope has ¿no image, lens cracked/broken inside¿.The customer reported problem was found at inspection before use.No death or injury and no impact to person or other was reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 event occurred due to the use of excessive force.Olympus will continue to monitor field performance for 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: 16136239
• MDR Text Key: 307071358
• Report Number: 9610773-2023-00176
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: 576397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2010
• 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