MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR 24/26FR LONGITUDIN

Model Number 27040JB130-S

Device Problem Sparking (2595)

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

Event Date 11/03/2023

Event Type  malfunction  

Event Description

It was reported that there was a spark and noise during the resection of the bladder tumor.During the procedure, there was a noise (like someone stepped on a balloon) was heard and a spark came out from the area where the cord from bipolar console connected to the bipolar cutting loop.The cutting loop was being used for the resection procedure.There was a black powdery residue seen on the gloves of the surgeon.There was no report of harm to the patient or the surgeon.New pair of gloves was changed.The electrical cord from the console to the loop was replaced with another cord.The procedure was continued and finished without further issue.

Manufacturer Narrative

Attempts to obtain more information and reported device were made; however, the reoprter has not responded to the request.Once new information is received or the reported device is returned for evaluation, 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).

• Brand Name: CUTTING LOOP, BIPOLAR 24/26FR LONGITUDIN
• Type of Device: CUTTING LOOP, BIPOLAR 24/26FR LONGITUDIN
• 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: 18871398
• MDR Text Key: 337650497
• Report Number: 9610617-2024-00054
• Device Sequence Number: 1
• Product Code: FAS
• 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,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040JB130-S
• Device Catalogue Number: 27040JB130-S
• Device Lot Number: 49713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• 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 Age: 77 YR
• Patient Sex: Male