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); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been 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 transcervical resection of the endometrium in saline (tcris) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.The fragment was not retrieved since it could not be located.The intended procedure was successfully completed with another hf resection electrode and there was no adverse event or patient injury.An x-ray confirmed that the loop wire remained inside the patient's uterus.However, rather than intervene, it was decided to watch and wait for the fragment to be excreted naturally during the patient's next menstrual cycle.Furthermore, the patient has since been discharged from hospital.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for evaluation/investigation.The visual inspection confirmed that the loop wire at the distal end of the hf resection electrode is broken off.Furthermore, the shaft of the hf resection electrode is bent.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 use error.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.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, MEDIUM, 12°, STERILE, SINGLE USE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6416576
• MDR Text Key: 70546745
• Report Number: 9610773-2017-00049
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120418
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 16158P01L002
• Other Device ID Number: 14042761051665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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
• Treatment: HF UNIT "ESG-400"; OLYMPUS TCRIS RESECTOSCOPE