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

Model Number UH801

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The reported product was not available for evaluation.The reported issue is tracked and trended.The complaint was notified by fda under the report from user facility: 0500390000-2022-8006.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the bipolar cord was found to have a burn mark upon completion of an urology procedure.The burn mark was located on the cord where the electrode connects to the cord.No additional information was provided.

• Brand Name: BIPOLAR CORD
• 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
• MDR Report Key: 17499381
• MDR Text Key: 320789378
• Report Number: 9610617-2023-00185
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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: R002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2021
• 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