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

Model Number 011050-10

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

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

Event Type  malfunction  

Event Description

It was reported that during use after 10 minutes, the loop detached from the side poles to which it is attached.Possible fragments not recovered.No harm to patient, user or third reported.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The product was returned on 2024-03-04.The investigation of the product was completed on 2024-03-20.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.The problem described by the customer can be confirmed.The working electrode is molten down completely - the neutral electrode is partially molten.There is no indication for a material-, manufacturing- or design-related failure.Most likely, the damage has been caused by excessive force applied to the cutting loop during application, led to a break of the cutting electrode and by touching the neutral electrode creating a shortcut which, in the end, melts the electrodes.The root cause of the reported issue can most likely be traced back to a usage-related failure.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLSR, SINGLE USE
• 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
• MDR Report Key: 18596855
• MDR Text Key: 333976021
• Report Number: 9610617-2024-00020
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011050-10
• Device Catalogue Number: 011050-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1