MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Model Number WA22302D

Device Problems Melted (1385); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not yet 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 the bladder tumor in saline (turis-bt) procedure, the surgical team noticed that the loop wire at the distal end of the hf resection electrode had melted and was partially missing as the physician was about to finish resecting the tumor.It is unknown when exactly this damage occurred and whether a fragment fell inside the patient.However, it was confirmed that no fragments remained inside the patient's bladder and the intended procedure was subsequently completed.Furthermore, there was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2015-12-25).The evaluation/investigation confirmed that the hf resection electrode is damaged and broken.The loop wire at the distal end has melted.However, no fragments could fall inside the patient as the platin-iridium wire has only melted through and thus no parts are actually missing.The present failure mode is typical for an unintended contact with other metal parts, e.G.Surgical instruments.Therefore this event/incident was attributed to use error and 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 pro re nata retrained to correctly use the olympus medical devices.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE
• 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, 75124 ; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5305374
• MDR Text Key: 34595283
• Report Number: 9610773-2015-00063
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 15168P01L001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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