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

Model Number 27040GP140-S

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  malfunction  

Event Description

It was reported that there was event with 27040gp140-s cutting loop, bipolar 24/26 fr.According to the information received from the salesrep: according to the facility the item broke off during the procedure and into the patients bladder.Patient harm was not noted at time of this report.Additional information has been requested but not yet received as of the date of this report.

Manufacturer Narrative

The product was received by manufacture, the complaint is confirmed the distal end is broken off and the yellow plastic is burnt at distal end temperature damage can be seen at proximal end.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).

Manufacturer Narrative

Per manufacture findings: the investigation revealed that the wire on the active and passive electrodes had melted in spots.This is an indication that there was a short circuit.Depending on the number of applications, the wire becomes thinner with each application, which could ultimately have led to the short circuit.On the other hand, a wire may also have bent, for example, so that the distance between the electrodes was too small, resulting in a short circuit.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: BIPOLAR CUTTING LOOP
• Type of Device: CUTTING LOOP 24/26 BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17070536
• MDR Text Key: 317645071
• Report Number: 9610617-2023-00114
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393208
• UDI-Public: 4048551393208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP140-S
• Device Catalogue Number: 27040GP140-S
• Device Lot Number: 37HB9087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other