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

Model Number WA22503D

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

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

Event Date 12/05/2016

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 the prostate in saline (turis-p) procedure, the surgical team noticed that the loop wire at the distal end of the hf resection electrode had broken off and was missing.The intended procedure was successfully completed with another hf resection electrode and there was no report of an adverse event or patient injury.It is unknown when exactly the loop wire broke off and whether it fell inside the patient.However, an x-ray examination showed no foreign objects inside the patient.

Manufacturer Narrative

Correction: is this a single-use device that was reprocessed and reused on a patient?; reprocessor name and address; usage of device.Additional information: it was reported that the single-use hf resection electrode had been reprocessed and reused on the patient.The user facility was not aware that the hf resection electrode is labeled for single-use.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4).The evaluation/investigation confirmed that the hf resection electrode is damaged.The loop wire at the distal end has split in the middle and the remaining wire ends are heavily bent.However, no fragments fell inside the patient, since the platin-iridium wire has melted through and thus no parts are actually missing.The present failure mode is consistent with an unintended contact with other metal parts, e.G.Surgical instruments, while the high-frequency output was activated.Furthermore, it was reported that the single-use hf resection electrode had been reprocessed and reused on the patient.The user facility was not aware that the hf resection electrode is labeled for single-use.Therefore, this event/incident was attributed to abnormal use/off-label use.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, LOOP, 24 FR., 0.2 WIRE, LARGE, 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: 6173199
• MDR Text Key: 62687207
• Report Number: 9610773-2016-00052
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2016

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: 09/30/2019
• Device Model Number: WA22503D
• Device Catalogue Number: WA22503D
• Device Lot Number: 14297P02L001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2016; 01/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS SURGMASTER ELECTROSURGICAL UNIT UES-40S