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

Model Number WA22302D

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.However, the exact cause of the user's experience and the reported phenomenon could not be determined yet since the evaluation/investigation is still ongoing.As soon as the investigation results and final evaluation are available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transcervical resection of the endometrium in saline (tcris) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.The fragment was not retrieved, but it was assumed that it was flushed out with irrigation fluid.No further information was provided, but the intended procedure was reportedly extended.

Manufacturer Narrative

Two hf resection electrodes from the same model and lot were returned to the manufacturer for investigation.The investigation confirmed that both hf resection electrodes are damaged.The loop wire at the distal end of one of the hf resection electrodes is broken off and missing.The loop wire of the second hf resection electrode is deformed.In addition, the fork tubes of both hf resection electrodes are deformed as well.The cause of this damage and the breakage of the loop wire is mechanical overload by the application of excessive force.Therefore, this event/incident was attributed to use error.Furthermore, 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 electrodes without showing any abnormalities.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.In addition, 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., STERILE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7489725
• MDR Text Key: 107457077
• Report Number: 9610773-2018-00046
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000016330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1