MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number A70941A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that when a ct scan was performed after a therapeutic arthroscopic shoulder cuff repair procedure had been performed, it was confirmed that a metal fragment had remained in the patient's body, which was identified as the tip of the telescope which was found to be missing.A follow-up procedure is being considered to remove the broken fragment.No further information was provided.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but olympus medical systems corporation (omsc), japan (received at omsc on 2022-06-03).The inspection at omsc confirmed the outer tube of the telescope to be severely damaged at its distal end.The outer tube of the sheath has melted and the optical fibers and the structure of the cover glass are heavily damaged.This damage was most likely caused by unintended contact with another surgical instrument and can thus be attributed to user error.A manufacturing and quality control review was performed for the affected serial number of the 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 results.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; 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: 14561468
• MDR Text Key: 293071736
• Report Number: 9610773-2022-00199
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04042761010542
• UDI-Public: 04042761010542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A70941A
• Device Catalogue Number: A70941A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2008
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female