MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIPOLAR HIGH FREQUENCY CORD, 300 CM

Model Number	26006M
Medical Device Problem Codes	Crack (1135); Sparking (2595); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of the hook instrument "sparked" and had broken off within the patient.Further information has been requested.No harm to patient, user or third parties reported.However, due to the reported spark as well as the broken off piece without information about the outcome, this case is deemed reportable for precautionary reasons.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Further information received on july 16, 2024 by the customer: during a laparoscopic assisted vaginal hysterectomy case the hook probe in question was in use by the consultant surgeon.As he was using the probe the cable sparked and separated from the adapter socket that fits onto the hook probe.The hook probe had been used several times during the case before this incident occurred [[?]] thankfully patient and staff unharmed during incident.Additionally, it was reported that it came to a short delay because of the event (<15 mins) and nothing fell into but on the patient.
Additional Manufacturer Narrative
Device evaluation: the complained products 26006m (unipolar high frequency cord, 300 cm) and 26775uf (coagulating and dissecting electrode) were received on july 12, 2024 at the manufacturing site and were therefore available for investigation.The investigation has been completed on august 12, 2024.During the inspection, the following was found: it was reported that a piece of the hook instrument sparked and had broken off within the patient when using the setup of high frequency cord and coagulating and dissecting electrode.During the investigation, no defect could be examined at the coagulating and dissecting electrode.The high-frequency cord was found broken into two pieces.This issue usually occurs if the cable was used over its intended lifetime.Due to external influences / forces the electrical resistance increases and the cable wires become hot or burns or could spark like the incident description.Especially, when the rubber surface of the cable is defective, the sparks can occur easily.According to the ifu, the user has to check the condition of the cable before each use to avoid this issue.Based on the available information and the results of the examination, there is no indication for a material, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to wear and tear.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: UNIPOLAR HIGH FREQUENCY CORD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19705431
• Report Number: 9610617-2024-00204
• Device Sequence Number: 3641424
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 04048551090916
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K945380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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: 26006M
• Device Catalogue Number: 26006M
• Device Lot Number: OS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 08/12/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 26006M - UNIPOLAR HIGH FREQUENCY CORD, 300 CM.
• Patient Sex: Unknown