MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LOOP,CUTTING,STERILE

Model Number	26055G-S
Medical Device Problem Codes	Material Fragmentation (1261); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device was disposed by the customer; thus, no product would be available for device evaluation.Once the evaluation is completed, a supplemental report would be made to the fda.This complaint will be tracked and trended.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the electrode cutting loop "disintegrated" during fibroid resection surgery.During the 3rd cuttign attempt of resecting the fibroid, the surgeon saw a red flash when contact with the tissue and the electrode loop disintegrated.The procedure was continued and completed without further issue.There was no abnormality or malfunction with the device prior to treatment.The power was set at 200 watts.It was confirmed there was nothing left inside of the patient.There was no report of injury to the patient.

• Brand Name: LOOP,CUTTING,STERILE
• Common Device Name: LOOP,CUTTING,STERILE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19651710
• Report Number: 2020550-2024-00089
• Device Sequence Number: 20489318
• Product Code: HIH
• UDI-Device Identifier: 04048551393505
• UDI-Public: 4048551393505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2024
• Report Date (Section F): 07/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: 26055G-S
• Device Catalogue Number: 26055G-S
• Device Lot Number: 46188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown