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

Model Number	26276B
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
Additional Manufacturer Narrative
The manufactures internal number is (b)(4).Investigation is on-going.Product findings are high temperature and discoloration to distal end of instrument.Related mdr filings for this event are 23-107, 23-109 and 23-110 from internal numbers (b)(4).The ifu states for the double lumen bipolar take apart consists of a handle, inner sheath, outer sheath and a working insert.Ifu97000168 ifu v3.0 11/2017 " warns to make sure that all electrical 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." the ifu additional notes "to keep the distal tip of any bipolar instrument in their field of view at all times.".
Event or Problem Description
It was reported that there was an issue with the product 26276b take-apart bipolar inner sheath.According to the information received during a tubal ligation the inner sheath along with instruments 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
Per manufacture: no abnormalities found, article 26276b show some light to deep scratch marks on the mantle surface of the shaft, which can be attributed to an external impact during reprocessing or handling.No corrective actions necessary as there is no critical and/or systematic deviation found during investigation.The manufactures internal number is (b)(4).

• Brand Name: TAKE-APART BIPOLAR
• Common Device Name: INNER SHEATH
• 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 ; 4244188247
• MDR Report Key: 16976439
• Report Number: 9610617-2023-00108
• Device Sequence Number: 16716819
• Product Code: GEI
• UDI-Device Identifier: 04048551065617
• UDI-Public: 4048551065617
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K962030
• 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): 10/04/2023

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: 26276B
• Device Catalogue Number: 26276B
• Device Lot Number: UP03
• 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: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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: 2627A26176HT26296HM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female