MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TAKE-APART BIPOLAR; RING HANDLE

Model Number	26296HM
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with the product 26296hm take-apart bipolar ring handle.According to the information received during a tubal ligation the instrument handle of the take-apart set malfunctioned causing the complete severing of the patient's fallopian tube, unknown side.Case was completed but not until after an unplanned salpingectomy was performed.Patient post operative condition is unknown.
Additional Manufacturer Narrative
The manufactures internal number is (b)(4).Investigation is on-going.Product was found to have gouges and scratches on top of handle connection.Related mdr filings for this event are (b)(4) from internal numbers (b)(4).The ifu states for the double lumen bipolar take apart consits of a handle, inner sheath, outer sheath and a working insert.Ifu 97000168 ifu v3.0 11/2017 " warns to make sure that all electical contacts on the instrument are thoroughly dried prior to being connected to the generator and to use the lowest possible current setting at which adequate cutting and coagulation can be achieved.".
Additional Manufacturer Narrative
Per manufacture: the 26296hm handpiece is damaged by a deep notch on the barrel.This damage was caused by blunt impact, such as dropping or a collision with another solid object.Internal karl storz complaint number (b)(4).

• Brand Name: TAKE-APART BIPOLAR
• Common Device Name: RING HANDLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16974904
• Report Number: 9610617-2023-00107
• Device Sequence Number: 17767100
• Product Code: HET
• UDI-Device Identifier: 04048551067086
• UDI-Public: 4048551067086
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K953809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 26296HM
• Device Catalogue Number: 26296HM
• Device Lot Number: PP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2023
• Supplement Date Received by Manufacturer: 07/23/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2627A.2627B.26176HT.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female