MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12; 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 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect medical devices have 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 devices are 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 bladder neck incision (bni) procedure, the rollers of two hf resection electrodes from different lots broke off and fell inside the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was successfully completed with a third hf resection electrode and there was no report about an adverse event or patient injury.This is report 1 out of 2.

Manufacturer Narrative

Correction: device available for evaluation? device evaluation: there was no device 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, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of the hf resection electrodes without showing any abnormalities.Furthermore, it was reported that the electrosurgical generator was used with incorrect settings.It was suspected that these settings were a little aggressive which probably caused the breakages.Therefore, this event/incident was attributed to use error.The case will be closed from 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 recommended settings of the electrosurgical generator and retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7276068
• MDR Text Key: 100488895
• Report Number: 9610773-2018-00013
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: PK951863
• 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: 04/06/2018

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 Expiration Date: 08/15/2022
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: P1790007
• Other Device ID Number: 14042761036815
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED OLYMPUS RESECTION SET AND ENDOSCOPE