MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE, SINGLE USE, 12 PC; HF-RESECTION ELECTRODES

Model Number A22201C

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2021

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 (turbt) procedure, the loop wire at the distal end of the hf resection electrode broke and fragments fell into the patient.It is unknown whether or not fragments may have remained inside the patient.An x-ray examination was to be performed to confirm that no fragments remained inside the patient, the results of which have not been provided.However, the intended procedure was completed using a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the loop wire at the distal end of the resection electrode is broken and the loop burnt down subsequently.During the announced x-ray examination no parts were found inside the patient.The cause of this event was attributed to wear and tear during use.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., 0.35 WIRE, 12, STERILE, SINGLE USE, 12 PC
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 11552490
• MDR Text Key: 244922299
• Report Number: 9610773-2021-00103
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K931763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 1000059075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1