MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CORD,HIGH FREQ,W/8MM PLUG,300CM,; CORD,HIGH FREQ PLUG

Model Number	26006M
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred in italy.It was reported that during a sleeve gastroscopy surgery, the electrosurgery device connected to the generator was used to restrain hemorrhage in the laparoscopic access port.In the course of such use first, ineffectiveness in transmitting the electrical pulse was detected, and soon after, a short circuit in the cable was detected, which forced to immediately suspend the procedure and provide cable replacement.No harm to the patient, user, or third reported.
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
Because the product was not sent back to karl storz, a detailed investigation can unfortunately not take place.The most probable root cause is that the cable was either severely bent several times and at one point the contact resistance was drastically increased, which then destroyed the cable when activated.Or there were residues of cleaning fluid in a connector which caused contact problems, this fluid became very hot when activated and destroyed the cable.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The cause for this issue is that the cable was bent too much, caused a cable break.According to ifu, the cable should have been tested before use and the "defect" should have been noticed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CORD,HIGH FREQ,W/8MM PLUG,300CM,
• Common Device Name: CORD,HIGH FREQ PLUG
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16074595
• Report Number: 9610617-2022-00343
• Device Sequence Number: 6334312
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 4048551090916
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/26/2023

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: 26006M
• Device Catalogue Number: 26006M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/26/2023; 04/27/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/06/2023; 05/26/2023
• 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
• Patient Sex: Unknown