MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP

Model Number 27040GP130-S

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: complaint confirmed.The distal end has broken off.There is temperature damage to the remaining cutting loop.There is also evidence of thermal damage to the proximal end.Investigation on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The ifu 97000002usca 02-2019, states " the product should not be manipulated or bent.Overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions".

Event Description

It was reported there was a malfunction with a 27040gp130-s cutting loop, bipolar 0.3mm, 24/26 fr.According to the information received "the bipolar top broke off while being used in the bladder" patient harm is not known at the date of this report.It is not known if the broken piece remained in patients body.Additional information has been requested but not yet receives as of the date of this report.

Manufacturer Narrative

Manufacturing site evaluation: based on the error pattern, the cutting wire has melted through/broken at the two bends (near the insulation including meltdowns on the insulation).The most probable root cause is that the wire became too hot and was damaged as a result.The ifu points out the correct handling.Internal complaint number is (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR
• Type of Device: BIPOLAR SINGLE USE CUTTING LOOP
• 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: ms. fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17148218
• MDR Text Key: 317759506
• Report Number: 9610617-2023-00129
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: XN09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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