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

Model Number WA22302D

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

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the cause of the reported event could not be conclusively determined.However this is a known error pattern which was most likely caused by used related wear and tear.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 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.

Event Description

Olympus was informed that during a therapeutic resection of cervical submucosal myoma procedure the loop wire of the resection electrode broke off and fell into the patient's body cavity.The broken fragments could be retrieved successfully.The intended procedure was successfully completed with a similar device without significant delay and there was no report about an adverse event or patient injury.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
• 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 ; 4940669662
• MDR Report Key: 13223412
• MDR Text Key: 285046276
• Report Number: 9610773-2022-00049
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000078192
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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: 31 YR
• Patient Sex: Female