MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°; HF-RESECTION ELECTRODES

Model Number A22251A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.However, the exact cause of the user's experience and the reported phenomenon could not be determined yet since the evaluation/investigation is still ongoing.As soon as the investigation results and final evaluation are available, this report will be updated.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the bladder (turb) procedure, the wire holding the roller at the distal end of the hf resection electrode broke, and the roller detached and fell inside the patient's bladder.However, no fragment remained inside the patient since the roller ball was reportedly retrieved.The intended procedure was successfully completed with another hf resection electrode and there was no report of any adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the roller at the distal end of the hf resection electrode is detached.This damage is most likely caused by using the monopolar hf resection electrode in bipolar mode.Therefore, this event/incident was attributed to abnormal use/off-label use.Furthermore, 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 from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6871867
• MDR Text Key: 87460512
• Report Number: 9610773-2017-00110
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK951863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22251A
• Device Catalogue Number: A22251A
• Device Lot Number: 16067P01L001
• Other Device ID Number: 04042761021562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1