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

Model Number 27040GP1-S

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Attempts to obtain information were made; however, there has been no response from the customer yet.Once the information is obtained and product is evaluated, a supplemental report would be made to the fda.The reported 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 bipolar cutting loop broke off inside the patient.No additional information has been provided.

Manufacturer Narrative

The reported device was not returned; however, the remaining devices from the same lot was returned to karl storz for evaluation.Evaluation of the devices from the same lot was performed and no malfunction was found with them.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

At the time of this report, the reported device has not been received for evaluation.According to the customer's description, it can be assumed that the cutting loop was pulled out in the distal area.The reason for this could be, for example, that the tensile force on the loop was too high without the hf current being activated or, on the other hand, that the activation time was too long and the wire burned out as a result.The ifu points out the correct handling.As the loop was not sent in for examination, it is not possible to carry out a more detailed examination to determine the cause of the fault.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Type of Device: CUTTING LOOP, BIPOLAR, 24/26 FR.
• 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: 18195497
• MDR Text Key: 328833307
• Report Number: 9610617-2023-00378
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 02/23/2024; 03/26/2024
• Supplement Dates FDA Received: 03/20/2024; 03/27/2024
• 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