MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 21FR BIPOLAR CUTTING LOOP

Model Number 26055GP1-S

Device Problem Break (1069)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that the cutting loop broke off inside the patient during the procedure.The broken piece was retrieved and a thorough view of the uterus was performed to ensure nothing was left behind.A new loop was used to finish the procedure.The generator was set on bipolar settings of 2 cuts and 3 coag.There was no report of injury to the patient.

Manufacturer Narrative

Reported device is not available to be returned for evaluation.Once the evaluation of the complaint 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).

• Brand Name: 21FR BIPOLAR CUTTING LOOP
• Type of Device: 21FR BIPOLAR CUTTING LOOP
• 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: 19144149
• MDR Text Key: 341368496
• Report Number: 9610617-2024-00098
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26055GP1-S
• Device Catalogue Number: 26055GP1-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• 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
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 103 KG