MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM; AUTOCLAVABLE TELESCOPE

Model Number A22003A

Device Problem Crack (1135)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

To date, no device has been returned.However, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.In general, the customer 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 by the nurse at the user facility that the 70-degree, 4-millimeter rigid telescope has ¿cracked lens¿ defect.The reported defect was found at inspection before use.No death injury or infection and no person or other was affected has been reported to olympus.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete device information.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 of the event was unable to be identified; however, the event likely occurred due to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 70°, 4 MM
• 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: 16065880
• MDR Text Key: 308276929
• Report Number: 9610773-2022-00785
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020862
• UDI-Public: 04042761020862
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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: A22003A
• Device Catalogue Number: A22003A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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