MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE; SUCTION CANNULA, REUSABLE

Model Number	WA51138A
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
An olympus representative reported on behalf of the customer that sparks occurred when the tip of the suction/irrigation tube, 5 x 360 mm, button, unipolar, for hiq+ handle made contact with the tissue while used together with a third-party electrosurgical generator during a laparoscopic colectomy resulting to a bowel burn and mesenteric artery damage requiring conversion from laparoscopic to open surgery, which was completed without further incident.The patient was admitted for routine post operative care after open surgery.No further problems were reported.The generator was set at soft core 80 watts.The device's output was inspected prior to use without any issues noted.
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: there were no traces of sparks on the metal tip and no dielectric breakdown.Therefore, it is believed that the product did not cause sparks.However, there were many scratches on the insulation coating, so it is likely that it occurred with other treatment tools.Furthermore, it was also noted that the service life of the product was considerably exceeded.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, it is likely that the reported event was attributed to user mishandling.This supplemental report includes an update to d9 and h3 from the initial medwatch.Also, additional information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION/IRRIGATION TUBE, 5 X 360 MM, BUTTON, UNIPOLAR, FOR HIQ+ HANDLE
• Common Device Name: SUCTION CANNULA, REUSABLE
• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17602595
• Report Number: 9610773-2023-02319
• Device Sequence Number: 6283910
• Product Code: GCJ
• UDI-Device Identifier: 04042761024341
• UDI-Public: 04042761024341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: WA51138A
• Device Lot Number: 166W-0190
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THIRD-PARTY GENERATOR.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown