MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number A22001A

Device Problem Break (1069)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has already been returned to an olympus shanghai regional repair center (rrc), (returned to the 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.

Event Description

Olympus was informed that the device's short contact pin was found to be loose during reprocessing.As the failure was found during reprocessing, no procedure or patient was involved.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus schanghai (osh) (returned to osh on 2022/12/07).The evaluation at osh confirmed that the connector pin is detached from the main body and the image is blurry.These error patterns are caused by excessive force and can thus be attributed to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the rigid scope without showing any abnormalities.The case will be closed on olympus side with no further actions and the user will be informed about the investigation results.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• 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 ; 4940669662
• MDR Report Key: 16058881
• MDR Text Key: 308543101
• Report Number: 9610773-2022-00761
• Device Sequence Number: 1
• Product Code: HIH
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22001A
• Device Catalogue Number: A22001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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