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

Model Number 26006M

Device Problems Fire (1245); Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Attempts were made to obtain more information and to have reported device return for evaluation; however, the reporter has not responded to the requests at the time of this report.If the reported device will be returned or the evaluation is completed, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the unipolar high frequency cord sparked and caught fire during the surgery.While using the electrode to cauterize, the center area of the cord sparked and caught surgical drape and arm cradle foam padding on fire.A small amount of water was used to extinguish the fire.The patient sustained a burn on he inner left forearm and also several spots on the left side of abdomen.

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Type of Device: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• 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: 19085265
• MDR Text Key: 339875515
• Report Number: 9610617-2024-00097
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26006M
• Device Catalogue Number: 26006M
• Device Lot Number: WZ01
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Race: White