MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 30°, WITH TROCAR TUBE CONNECTOR; RIGID ARTHROSCOPE

Model Number WA4KA430

Device Problem Crack (1135)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

The customer reported to olympus, the telescope lens were cracked.The issue was found during a diagnostic procedure.There were no reports of patient harm.

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation but is expected.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: TELESCOPE ¿ULTRA¿, 4 MM, 30°, WITH TROCAR TUBE CONNECTOR
• Type of Device: RIGID ARTHROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18590753
• MDR Text Key: 334839656
• Report Number: 9610773-2024-00261
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04042761083010
• UDI-Public: 04042761083010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA4KA430
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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