MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD

Model Number UH801

Device Problems Break (1069); Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

Reported device is being returned for evaluation.Once the evaluation is complete, 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 cable was having issue during the procedure.While the electrode was inside the patient, the surgeon heard an audible pop with a spark of current and burning smell.The facility engineer found the cable to have a break.The procedure was aborted due to the failure; however, there was no report of injury to the patient.Karl storz generator was used during the procedure with the preset settings.

• Brand Name: BIPOLAR HIGH FREQUENCY CORD
• Type of Device: BIPOLAR 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 ; 4242188247
• MDR Report Key: 18297430
• MDR Text Key: 330143483
• Report Number: 9610617-2023-00392
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UH801
• Device Catalogue Number: UH801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2023
• 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: 76 YR
• Patient Sex: Male