MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HIGH FREQUEBCY CORD; MONOPOLAR HIGH FREQUENCY CORD 8MM PLUG

Model Number	26006M
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product requested but will not be returned.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).In addition an event that could be considered as similar to this one occurred in the timeframe of 02/09/2021 - 03-08/2023 could be found and could be considered and caused or contributed to a death or serious injury.The product event more likely occurred due to over usage of the ifu recommendation of life is determined by wear and preparation methods.
Event or Problem Description
It was reported that there was an event with a 26006m monopolar high frequency cord.According to the information received, during a turb procedure, there was an apparent breakage at the neck of headpiece that connects to bovie plugin, joint where handpiece connects to cable.Flames were seen coming from the monopolar bugby cord while in use.There was no harm to patient or to user.
Additional Manufacturer Narrative
Per the manufacture : the product was not returned to karl storz tuttlingen.It was reported that flames have occurred when using the unipolar high frequency cord.This issue normally occurs if the cable was used over its intended lifetime.Due to external influences / forces the electrical resistance increases and the cable become hot or burns.According to the ifu, the user has to check the condition of the cable before each use to avoid this issue.Based on the given facts we set the root cause to wearing.The product event more likely occurred due to over usage of the ifu recommendation of life is determined by wear and preparation methods.

• Brand Name: HIGH FREQUEBCY CORD
• Common Device Name: MONOPOLAR HIGH FREQUENCY CORD 8MM PLUG
• 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 ; 4242188100
• MDR Report Key: 16511402
• Report Number: 9610617-2023-00054
• Device Sequence Number: 5581233
• Product Code: GEI
• UDI-Device Identifier: 04048551090916
• UDI-Public: 4048551090916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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: 02/09/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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