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

Model Number 27040GP1-S

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The electrode insulation has evidence of melting use, the tip was not returned by facility.

Event Description

Allegedly, per the facility, during a turp procedure, the electrode broke off inside the patient.The broken part of the electrode was removed with no harm to the patient.A new electrode was used to complete the procedure with no further intervention required.

Manufacturer Narrative

Additional evaluation findings: the loop wire has broken off on one side.Both insulations were pulled out of the rod.One insulation was pulled so far out of the rod that it was not sent in and is therefore not available for investigation.The product was presumably pre damaged by mechanical action such as bending the sling back to its original position.During use, the sling was bent again by the application of force through tissue contact without hf activation, causing it to break.Due to the lack of electrical function and the force effect, the broken loop part was pulled out of the linkage on the opposite side with the insulation.

• 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
• MDR Report Key: 10864327
• MDR Text Key: 217141541
• Report Number: 9610617-2020-00123
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (y/n): N
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: VQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention