MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, WIDEANGLE, 4 MM; OLYMPUS HYSTERORESECTOSCOPE

Model Number A22005A

Device Problems Break (1069); Mechanical Problem (1384); Melted (1385); Material Separation (1562)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that when using a telescope, 30°, wideangle, 4 mm, the image was blurry.The procedure was completed with the same device.There was no procedural delay, or no patient harm associated with the device.The device was returned and evaluated, and upon estimation, the lens was damaged with displacement, the distal end was burnt and worn, and the direction pin was damaged.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation (blurry image) was confirmed.In addition to the damaged lens with displacement, the burnt and worn distal end, and the damaged direction pin, additional evaluation findings were as follows: the outer tube was skewed, and the label of the eyepiece was worn.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

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 reported event is unable to be determined.However, the cause of the event is likely due to excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 30°, WIDEANGLE, 4 MM
• Type of Device: OLYMPUS HYSTERORESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 17455932
• MDR Text Key: 321231891
• Report Number: 9610773-2023-02133
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020886
• UDI-Public: 04042761020886
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22005A
• Device Lot Number: 701814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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
• Treatment: OTV-S7PRO VISERA PRO VIDEO SYSTEM CENTER