MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 61873 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE; CUTTING LOOP, BIPOLAR

Model Number 26040GP

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2023

Event Type  Injury  

Event Description

It was reported that the upper part of the cutting electrode broke during cutting.The hf generator was set as usual.Due to the reason that a trophyscope to campo had to be used/ inserted to recover the broken parts, an additional medical intervention was required, and the surgery was prolonged.Exact amount of prolongation is not known currently.

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).

• Brand Name: 61873 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
• Type of Device: CUTTING LOOP, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17931553
• MDR Text Key: 325622074
• Report Number: 2020550-2023-00288
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2023

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: 26040GP
• Device Catalogue Number: 26040GP
• Device Lot Number: NO08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention