MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE; HF-RESECTION ELECTRODES

Catalog Number WA22302D

Device Problems Bent (1059); Break (1069)

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

Event Date 08/21/2014

Event Type  malfunction  

Event Description

Olympus was informed that during preparation for use prior to an unspecified resection of the myoma procedure, the user noticed that the loop wire of the suspected medical device was bent.However, the hf resection electrode was used anyway and the loop wire subsequently broke off inside the patient.An identical product problem/malfunction reportedly occurred again with a second similar device.The intended procedure was finally completed without further complications by using a third hf resection electrode.It is unknown whether a fragment/part remained inside the patient.However, no pieces were found during search and an x-ray of the pelvis was taken where no foreign objects were noted.There was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not yet returned to the manufacturer 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 as a manufacturing and quality control review was performed for the affected lot number of the hf resection electrodes without showing any abnormalities related to function and safety.Furthermore, as clearly stated in the instructions, warped electrodes, defective insulation and cracked or irregular cutting loops represent a danger to the patient and the surgeon.Defective instruments must not be used.If the product is damaged or does not function properly, an olympus representative or an authorized service center has to be contacted.The user apparently did not follow these instructions as he reportedly used the hf resection electrode device despite a bent and thus irregular loop wire.Therefore, this incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions.However, the incident will be recorded for trending and surveillance purposes.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; GM ; 0669662955
• MDR Report Key: 4105251
• MDR Text Key: 16629162
• Report Number: 9610773-2014-00040
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2014

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 Catalogue Number: WA22302D
• Device Lot Number: 14015P01L001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (OUTPUT POWER LEVEL: 230W/100W); OLYMPUS UES-40 ELECTROSURGICAL GENERATOR
• Patient Outcome(s): Other