MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR ELECTRODE 24/26 FR; CUTTING LOOP

Model Number	27040GP1-S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the product found the distal loop is broken from one side of the housing's shaft.Additionally, the insulation at the proximal end has black residue and the shaft is bent.A complaint review for similar articles for the timeframe 20-jul-2020 - 23-sep-2022 was performed.Similar complaints could be found.In one of these cases, an additional medical intervention was necessary.Consequently, it is required to a report to fda.
Event or Problem Description
The manufacturer's complaint reference number for this case is (b)(4).According to the information received a bipolar electrode broke during the procedure.It was reported that there was no injury to patient, user or third due to this malfunction.All parts were retrieved, and the procedure was completed with another loop.
Additional Manufacturer Narrative
Follow up dates from 11/9/2022 - 12/14/2022 went unanswered by rep/facility for exchange approval.The product was sent to kst/mfr.To complete evaluation on 01/03/2023.On 01/17/2023 received email from kst/mfr.Stating that the product had not been received and "apparent cause, based on the customer's description, is a mechanical overload due to excessive force.Kst/mfr.Approved a credit note on 04/17/2023 stating " warranty claim for the returned article is justified.Replacement article sent to facility on 05/04/2023.

• Brand Name: BIPOLAR ELECTRODE 24/26 FR
• Common Device Name: CUTTING LOOP
• 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
• MDR Report Key: 15519149
• Report Number: 9610617-2022-00274
• Device Sequence Number: 11431497
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• 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): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: ON05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Sex: Unknown