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

Model Number 011160-01

Device Problem Material Fragmentation (1261)

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

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that there was a rupture of the loop during adenoma resection after bipolar enucleation.Consequence: extraction of the broken piece and prolongation of surgical time.It was furthermore confirmed that the procedure was completed successfully and there were no adverse consequences for the patient.However, a medical/ surgical/ diagnostical intervention was required and the surgery was prolonged between 15 and 60 minutes.

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

Result of investigation: upon investigation of the returned product it could be confirmed that the working electrode is broken off at the power supplying side and partially ruptured out of the passive side.By detailed inspection it was visible that the break surfaces shows a ductile appearance.Due to the fact, that the broken surface shows a ductile appearance, it is most likely that the cutting loop got mechanically overloaded during application.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, 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: 18536471
• MDR Text Key: 333154218
• Report Number: 9610617-2024-00012
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221893
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-01
• Device Catalogue Number: 011160-01
• Device Lot Number: ZN22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention