MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; HF-ELECTRODES

Model Number WA47787A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

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 hysteroscopy procedure the loop wire at the distal end of the hf electrode broke off and fell into the patient.However, no fragments remained inside the patient since an abdominal x-ray examination was performed and no foreign objects could be located.The intended procedure was completed using another similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the loop wire at the distal end of the hf electrode is broken off due to brittle failure.Thus, the reported event/incident was attributed to component failure.This is a known error pattern, which has already been examined in the past.However, it was assessed that a material change was not required based on the very low number of occurrences of this failure mode.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 on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING
• Type of Device: HF-ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): GYRUS MEDICAL LTD.; fortran road; st. mellons; cardiff
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12933374
• MDR Text Key: 285831675
• Report Number: 9610773-2021-00348
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 14042761086261
• UDI-Public: 14042761086261
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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 Model Number: WA47787A
• Device Catalogue Number: WA47787A
• Device Lot Number: U2106140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 02/23/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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: 54 YR
• Patient Sex: Female