MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

Model Number A4674A

Device Problem Defective Component (2292)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the telescope, 3 mm, 30°, wideangle, autoclavable mirror body was bent and the image was blurry.There was no patient harm associated with the event.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation of the mirror body being bent was not confirmed.The customer allegation of the image was blurry was confirmed.Additionally, the lens was damaged.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

• Brand Name: TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
• Type of Device: TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18424915
• MDR Text Key: 331912575
• Report Number: 9610773-2024-00043
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761006361
• UDI-Public: 04042761006361
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K904939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4674A
• Device Lot Number: 803737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• 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