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

Model Number 26055G-S

Device Problems Material Disintegration (1177); Flare or Flash (2942)

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

Event Date 02/27/2024

Event Type  malfunction  

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.The event is filed under internal karl storz complaint id: (b)(4).

Event 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
• Type of Device: LOOP,CUTTING,STERILE
• 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: 18969826
• MDR Text Key: 338502650
• Report Number: 9610617-2024-00089
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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