MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, 12, STERILE, SINGLE USE,; HF-RESECTION ELECTRODES

Model Number A22201D

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has 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 device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transcervical resection of fibroids (tcrf) procedure, the loop wire at the distal end of the hf-resection electrode detached.It is unknown whether the detached parts remained inside the patient¿s body since they could not be found within an x-ray examination of the patient or when searching the facility.The intended procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The investigation confirmed that the loop wire at the distal end of the resection electrode is broken off and is missing.Furthermore, both sides of the fork insulation show signs of massive heat influence.It cannot be determined whether this damage was caused by an incorrect combination with a telescope or by subjecting the loop to excessive force.In both cases however, this event/incident can be attributed to use error.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 electrode without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, 12, STERILE, SINGLE USE,
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10895237
• MDR Text Key: 226955377
• Report Number: 9610773-2020-00277
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 14042761036655
• UDI-Public: 14042761036655
• Combination Product (y/n): N
• PMA/PMN Number: K903323
• 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: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201D
• Device Catalogue Number: A22201D
• Device Lot Number: 16014P03L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1