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 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

This is a single use electrode.The electrode was not returned and therefore, could not be evaluated.

Event Description

Allegedly, per the facility, during a laser cystolitholapaxy with turp procedure, the electrode broke off inside the patient.The broken part of the electrode was removed with no harm to the patient, and a radiograph was taken of the bladder which showed no evidence of remaining fragment.A new electrode was used to complete the procedure with no further intervention required.

Manufacturer Narrative

The device was manufactured in dec.2013 and therefore is suspected to be in use for approx.7 years.The breakage surface looks homogenous and does not show any discolorations which suspects high force initiation.On the joint surface of the broken part dents are visible.The root cause most likely is mechanical overload which caused the breakage of the grasper.As described in the event description received, excessive force was used.The instrument is intended to grasp bowel not for handling or retracting heavy tissue.No indication for a material or manufacturing issue found during investigation.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

• 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,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10364607
• MDR Text Key: 201608718
• Report Number: 9610617-2020-00076
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37LI3018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 06/29/2020; 08/11/2022
• Supplement Dates FDA Received: 08/09/2022; 08/11/2022
• 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): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 62 KG