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

Model Number WA22306D

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

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

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 transurethral resection of a bladder tumor (tur-bt) procedure, the loop wire at the distal end of the hf-resection electrode was damaged.It is unknown whether some fragments detached and fell into the patient's body cavity.The loop wire at the distal end was peeled off and curled on one side.However, no fragments were found inside the patient¿s body.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Additional information: d4 - lot number; d4; expiration date; h4 - device manufacturer date device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation (omsc), japan (returned to omsc on 19.03.2021).The evaluation at omsc confirmed that the loop wire at the distal end of the resection electrode is broken and the ends of the wire have melted into balls.Therefore, it is concluded that no parts fell into the patient's body cavity.Also, no fragments were found, when the patient was examined.Furthermore, the evaluation at omsc confirmed a short circuit between the electrode and the inner sheath.Therefore, this event/incident was attributed to use error.However, 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, STERILE, SINGLE USE, FOR TURIS
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11453639
• MDR Text Key: 239465062
• Report Number: 9610773-2021-00093
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 1000060689
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1