MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR; ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

Model Number WA22306D

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the service center for evaluation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.However, if the device is returned for evaluation or additional significant information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was notified by a user facility that during a procedure, the distal loop of the device broke off inside the patient.The surgical team was unable to remove the loop fragment under fluoroscopy.It was reported that the procedure was for therapeutic purposes.It has not been determined at this time if there was any patient injury as the patient was still under anesthesia when the event occurred.No additional information has been provided at this time.

Event Description

Additional information was provided by the user facility stating that the procedure performed was a resection of uterine fibroids.It was during the resection when the piece broke off into the patient.The piece was not retrieved during the procedure.There was no harm to the patient.No additional information was provided.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Type of Device: ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 9885559
• MDR Text Key: 186560618
• Report Number: 9610773-2020-00099
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention