MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD, 400 CM

Model Number UH801

Device Problems Thermal Decomposition of Device (1071); Material Frayed (1262)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

Follow-ups were made to obtain reported power cord for evaluation.The power cord is still pending to be sent back by the facility.Once reported power cord is returned and evaluated, 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 high frequency bipolar cord made a "pop" sound and stopped working at the beginning of the procedure.A break in the outer layer of the cord was discovered.The frayed piece of the cord was visible after the pop sound.The cord was replaced with another karl storz cord and the procedure continued without issue.There was no report of injury to the patient.There was no abnormality or issue found with the cord prior to use.It was not known what was the setting of the generator when the event happened.

• Brand Name: BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Type of Device: BIPOLAR HIGH FREQUENCY CORD, 400 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 ; 4242188247
• MDR Report Key: 18252999
• MDR Text Key: 329547662
• Report Number: 9610617-2023-00386
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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
• Device Lot Number: VO01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2023
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 107 KG