MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22306D

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

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

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 (tcr) procedure at an unknown date, the loop wire at the distal end of the hf resection electrode was damaged and wire fragments possibly may have fallen into the patient.However, an x-ray examination was performed but no fragments could be located.No further information was provided but there was no report about an adverse event or patient injury.

Event Description

Olympus was informed that during a therapeutic transcervical resection (tcr) procedure at an unknown date, a spark occurred that caused the entire screen to turn white and then the loop wire at the distal end of the hf resection electrode broke and wire fragments possibly may have fallen into the patient.However, an x-ray examination was performed but no fragments could be located.No further information was provided but there was no report about an adverse event or patient injury.

Manufacturer Narrative

Additional information: b5 - describe event or problem; d4 - lot number, expiration date; h4 - device manufacturer date corrected data: d1 - brand name; d2 - device product code; d4 - model number, catalog number; g9 - pma/510(k) number 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.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation.Therefore, the investigation/evaluation was performed exclusively on the basis of the pictures/information provided.According to the photos provided, the electrode¿s cutting wire is broken and the ends of the wire have melted into balls.There are also distinct traces of heat development on the insulation sleeves and residues of dried up irrigation fluid.The damage was 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 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 and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30, 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: 10405989
• MDR Text Key: 204379304
• Report Number: 9610773-2020-00188
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761021319
• UDI-Public: 04042761021319
• 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,Followup
• Report Date: 11/02/2020

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: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000053804
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 10/29/2020
• Supplement Dates FDA Received: 08/26/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1