MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SHAFT "HIQ+", 5 X 330 MM; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	A60800A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch report mw5160877 received: "patient went in for surgery to assess why peritoneal dialysis catheter was not working.While in surgery the surgeon had to dissect abdominal adhesions and when doing so caused a serosal injury to the patient's bowel due to an electrocautery malfunction.Patient was unable to receive a new peritoneal dialysis catheter and has since had to receive a fistula for future hemodialysis." additional information was received from the customer that the procedure was converted from a laparoscopic to open surgery.The provider used several 3-0 silk sutures over the area of injury during surgery.The procedure was completed with another device.The serosal bowel injury caused the patient to have to switch from peritoneal dialysis to hemodialysis, requiring hospital stays for the hemodialysis.There were no further reports of patient harm.The customer reported the subject device had a small hole in the insulation of the device.This report is related to the following linked patient identifier: (b)(6).

• Brand Name: SHAFT "HIQ+", 5 X 330 MM
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 21119110
• Report Number: 2429304-2025-00023
• Device Sequence Number: 8760379
• Product Code: HET
• UDI-Device Identifier: 04042761009843
• UDI-Public: 04042761009843
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025
• Report Date (Section F): 01/09/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOVIE GENERATOR; COVIDIEN MONOPOLAR CORD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 01/09/2025