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

Model Number A22001A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.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.

Event Description

The customer reported to olympus, encountered vitreous fracture to the telescope.The issue was found during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.In addition, the following non-reportable malfunctions were found during the device evaluation the dry ring is burst, red deposit on main body, the kl connection loose.Furthermore, there were proximal dents on the outer tube.Lastly normal signs of use were noted on the telescope.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 reported event is unable to be determined.However, the cause of the event is likely due to excessive/frequent use and/or unsuited/inappropriate handling and/or the apply of external force by fall, impact or shock.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: -
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17831483
• MDR Text Key: 324433615
• Report Number: 9610773-2023-02737
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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: A22001A
• Device Lot Number: 524862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2006
• 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