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

Model Number UH801

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that or staff noted a burn mark on the karl storz high frequency bipolar cord (uh801) upon completion of the urology procedure.The burn mark was located on the cord where the electrode connects to the cord.This was the 3rd instance of staff noting a burn mark on a karl storz uh801 bipolar cord following the completion of a procedure.

• 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 Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17355971
• MDR Text Key: 319694001
• Report Number: 9610617-2023-00170
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551388778
• UDI-Public: 4048551388778
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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: U003-00814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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