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

Model Number A22201B

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

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 an unspecified therapeutic procedure, the loop wire at the distal end of the hf resection electrode detached and fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided but there was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2020-08-27).The evaluation confirmed that the loop wire at the distal end of the resection electrode is broken on both sides.There is a melting point at one of the wire ends as well as distinct signs of thermal damage on one of the insulating tubes.Furthermore, the electrode fork is deformed due to the missing loop.The reported damage can most likely be attributed to use-related wear and tear.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.However, the reported phenomenon 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
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10447562
• MDR Text Key: 225942137
• Report Number: 9610773-2020-00195
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761021319
• UDI-Public: 04042761021319
• 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: 11/26/2020

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: A22201B
• Device Catalogue Number: A22201B
• Device Lot Number: 1000019354
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1