MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.

Model Number 27040GP1-S

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/01/2021

Event Type  Injury  

Event Description

It was reported that physician was using the original designed bipolar loops, but switched to monopolar as the bipolar loops were too fragile.She has recently tried the new designed bipolar loop, which has the additional small, neutral loop on the opposite end.This neutral loop should not get heated, but in her case it did and burned tissue in a location that was not intended.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Type of Device: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17401477
• MDR Text Key: 319884881
• Report Number: 2020550-2023-00188
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/17/2023,07/26/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37LJ2109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other