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

Model Number A22251C

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

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

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation / investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user's experience and the reported phenomenon could not be conclusively determined and is being judged as unknown.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.

Event Description

Olympus was informed that during a therapeutic transurethral resection (tur) procedure, the roller ball at the distal end of the hf resection electrode broke off and fell into the patient¿s bladder.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided but the intended procedure was completed successfully using a similar device and there was no report about an adverse event or patient injury.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 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: 9236951
• MDR Text Key: 165053106
• Report Number: 9610773-2019-00146
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (y/n): N
• PMA/PMN Number: K951863
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 1000030183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1