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 Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The hf resection electrode 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, 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 hysteroscopic transcervical resection (tcr) procedure, it was noticed that the loop wire at the distal end of the hf resection electrode had broken off inside the patient's uterus.The fragments were not retrieved, since they were lodged inside the myometrium, out of reach of the hysteroscope.This was confirmed post procedure by ultrasound and x-ray where a foreign object was found in the patient's uterus.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.Furthermore, it was reported that the patient was released the same day.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the hf resection electrode is damaged and broken.The loop wire at the distal end is broken off completely and missing.Furthermore, one of the fork tubes is slightly deformed and dented.The other fork tube shows slight abrasion.The cause of this damage and the breakage of the loop wire is mechanical overload by the application of excessive force.Therefore, this event/incident was attributed to abnormal use/off-label use.Furthermore, a material or quality problem can be excluded, since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities related to function and safety.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: 5403561
• MDR Text Key: 37744195
• Report Number: 9610773-2016-00008
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 02/02/2016

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: 02/29/2020
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 15065P01L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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
• Patient Age: 48 YR