MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SHAFT "HIQ+", 5 X 330 MM; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR

Model Number	A60800A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Burn(s) (1757); Necrosis (1971)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed that during a therapeutic laparoscopic colectomy procedure the patient sustained a burn injury in the intestines due to a damaged insulation.The burn is thought to have reached the serosa, but there is a possibility that it may have reached the muscle layer.Suturing was performed on the burn site.
Additional 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.
Additional 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 findings are as follows: the halar coating of the shaft serving as an insulation has become hardened due to frequent reprocessing and shows indentations or cuts.Also, there are short-circuit marks in the distal area.Also, the instrument¿s marking is deteriorated, and the blue color ring is faded.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the reported issue is attributed to customer error and customer infrastructure.The customer used a damaged or worn instrument by not following the directions provided in the instructions for use (ifu).The shaft shows clear and severe signs of wear and tear in all its areas.Also, the product is designed for 400x reprocessing cycles.Therefore, the expected service life must be considered as considerably exceeded.This supplemental report includes a correction to the following fields: a1, b3, d9, e1, e2, e3, g2, h6 and h8.Additional information has been added to d4, d8 and h4.Also, an update has been made to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SHAFT "HIQ+", 5 X 330 MM
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• 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 ; 4940669662955
• MDR Report Key: 16415703
• Report Number: 9610773-2023-00546
• Device Sequence Number: 17487413
• Product Code: GCJ
• UDI-Device Identifier: 04042761009843
• UDI-Public: 04042761009843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A60800A
• Device Catalogue Number: A60800A
• Device Lot Number: 15XW-1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown