MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE; ARTHROSCOPE

Model Number A70941A

Device Problems Break (1069); Melted (1385)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The evaluation found lens damage, light guide damage, burning/ melting of gold painting on the outer tube and poor lighting due to a broken light guide.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the telescope "trueview ii", has lens damage.The defect was found during reprocessing.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found: lens damage, light guide damage, and burning/ melting of gold painting on the outer tube.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunctions reported by the customer and found during evaluation.

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 of the event could not be determined although it can be presumed it was due to user error, improper handling as well as application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17752319
• MDR Text Key: 323701966
• Report Number: 9610773-2023-02587
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04042761010542
• UDI-Public: 04042761010542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A70941A
• Device Lot Number: 611038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2011
• 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