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

Model Number	26176HT
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.There is discoloration to the proximal end of instrument.High temperature defect on distal end that is discolored.Insulation on distal end has two separate tears, both on the same jaw.One on the outside and one on the inside.Related mdr filings for this event are (b)(4) from internal numbers (b)(4).The ifu states for the double lumen bipolar take apart consist of a handle, inner sheath, outer sheath and a working insert.Ifu 97000168 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.Always keep the distal tip of any bipolar instrument in their field of view.".
Event or Problem Description
It was reported that there was an issue with the product 26176ht take-apart bipolar forceps insert.According to the information received during a tubal ligation the forceps insert 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
Internal karl storz complaint number (b)(4).During the inspection of article 26176ht, it was determined that the hf connector in the proximal area is made of the wrong material.The component of the article in question is made of brass but should be made of 1.4305 according to the drawing.Furthermore, the shaft is unlabelled, which indicates that the article has been repaired by a third party.
Additional Manufacturer Narrative
Internal karl storz complaint number (b)(4).During the inspection of article 26176ht, it was determined that the hf connector in the proximal area is made of the wrong material.The component of the article in question is made of brass but should be made of 1.4305 according to the drawing.Furthermore, the shaft is unlabelled, which indicates that the article has been repaired by a third party.

• Brand Name: TAKE-APART BIPOLAR
• Common Device Name: FORCEPS INSERT
• 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 ; 4242488247
• MDR Report Key: 16978942
• Report Number: 9610617-2023-00109
• Device Sequence Number: 19405643
• Product Code: HET
• UDI-Device Identifier: 04048551100059
• UDI-Public: 4048551100059
• 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,Followup
• Report Date (Section B): 08/21/2023

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: 26176HT
• Device Catalogue Number: 26176HT
• Device Lot Number: NC
• 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: 07/07/2023; 07/07/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/21/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2007
• 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: 2627A2627B26296HM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female