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 12/12/2022

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 via medwatch report (b)(4): the surgeon was performing a transurethral resection of the prostate (turp) and used the storz bipolar cutting loop, (diameter 0.40mm).The product was defective.The top prongs on the device came off in the patient's urethra.The surgeon was able to remove the pieces and applied a 22 fr 3 way foley catheter for hematuria.Patient harm was not noted at time of this report as the catheter was inserted for prevention.Additional information has been requested but not yet received as of the date of this report.

Manufacturer Narrative

The product was discarded by accident per the sales representative, therefore, no evaluation has been completed.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 manufactures findings: based on the customer's description, part of the loop wire at the distal end has come out and has fallen into the patient.This can happen, for example, if the sling is pulled with too high a tensile force in the application.Since the article is not available/sent in for examination, no precise statement can be made.An excessive force effect would be due to the customer.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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16335626
• MDR Text Key: 309165481
• Report Number: 9610617-2023-00030
• 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: 08/10/2023

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: 27040GP140-S
• Device Catalogue Number: 27040GP140-S
• Device Lot Number: 37HB9087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male