MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; RIGID SCOPE

Model Number A4674A

Device Problem Optical Problem (3001)

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

Event Type  malfunction  

Event Description

Olympus was informed that during preparation for use for an unspecified procedure at an unknown date, the telescope displayed a blurred image.No further information was provided but there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device has already been returned to an olympus regional repair center (rrc) in singapore (returned to rrc on (b)(6) 2022).However, since the evaluation/investigation is still ongoing, the exact cause of the user's experience and the reported phenomenon has not been determined yet.This report will be updated if additional significant information becomes available or once the evaluation/investigation has been completed.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation, but to an olympus regional repair center (rrc) in singapore (returned to rrc on 29-11-2022).The evaluation/investigation at the rrc confirmed the occurrence of the reported ¿blurry image¿ and traced it back to foreign material inside the eyepiece.Thus, the reported incident was attributed to use error.The rrc also found the outer tube slightly bent and the guide pin missing.These damages were caused by excessive force and can thus also be attributed to use error.However, they are not directly related to the reported image problem.A manufacturing and quality control review was performed for the affected serial number of the rigid telescope without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation result.

• Brand Name: TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
• Type of Device: RIGID SCOPE
• 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: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 16058539
• MDR Text Key: 308526591
• Report Number: 9610773-2022-00755
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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: A4674A
• Device Catalogue Number: A4674A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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