MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number 011160-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.

Event Description

It was reported that there was an issue with the product.The cutting element of the loops broke on the first activation.One of the electrodes broke in the patient's bladder.The broken items were recovered directly during surgery and the surgery was prolonged for 30 minutes.Due to the prolongation of the surgery, the patient was hospitalized for one night.The patient condition post-surgery is fine, there was no harm reported.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The complaint products were received on 2022-12-07.4 devices were returned to the manufacturer.Visual examination of the affected devices shows that two of the returned cutting electrodes are broken at the exit of the yellow insulation on the passive rod of the electrode.On the two other electrodes, the cutting loop is completely broken off at the level of the exit of the yellow insulation.The device history records have been checked and were found to be according to our specifications.There is no indication of a manufacturing error.Based on the investigation results, all electrodes show signs of forced breakage.Consequently, the root cause of the reported issue can be traced back to a usage-related failure by the application of too much force during usage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15925858
• MDR Text Key: 304917468
• Report Number: 9610617-2022-00323
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551411087
• UDI-Public: 4048551411087
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

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: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 838048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/07/2022; 01/09/2023
• Supplement Dates FDA Received: 01/04/2023; 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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): Hospitalization