MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12; HF-RESECTION ELECTRODES

Model Number A22201A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect medical devices have not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified transcervical resection of the endometrium (tcre) procedure, the loop wire at the distal end of two hf resection electrodes broke and one of them fell inside the patient.The loop wire was reportedly not retrieved but an examination by x-ray showed no foreign objects inside the patient.It was assumed that the fragment was possibly flushed out with irrigation fluid.However, the intended procedure was aborted.No further information was provided but there was no report about an adverse event or patient injury.

Manufacturer Narrative

Additional information: lot number; device manufacturer date; device evaluation: this evaluation/investigation report refers to the hf resection electrode where the loop wire reportedly broke off completely and fell inside the patient.During the evaluation/investigation it was confirmed that the loop wire at the distal end of the hf resection electrode broke off and is missing.In addition, the ceramic insulation at the distal end is deformed and there is also a deformation at the electrode¿s proximal end.The damage at both the distal and the proximal end of the electrode was caused by excessive force and the event/incident was thus attributed to use error.The damage at the proximal end is considered to be unrelated to the reported incident though.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7746146
• MDR Text Key: 116105014
• Report Number: 9610773-2018-00069
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761021302
• UDI-Public: 04042761021302
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201A
• Device Catalogue Number: A22201A
• Device Lot Number: 15051P03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1