MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE

Model Number WA22306D

Device Problem Break (1069)

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

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510k: additional 510k number: k120418.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The user facility reported to olympus that during use of the hf- resection electrode, loop, 24 fr., 0,2 wire the device broke inside of the patient.The physician managed to removed it from the patient, and another device was opened to complete the procedure.Additionally, the procedure was delayed by 30 minutes.Attempts for additional information are in progress.

Manufacturer Narrative

This supplemental report was submitted to provide the results of the legal manufacturer¿s investigation.Olympus followed up with the user facility to obtain additional information regarding the reported event but no information was obtained.The dhr review showed there is no non-conformity associated with this device with respect to the described issue and the device was manufactured according to valid instructions and met all specifications.The most probable cause of the reported issue is most likely due to wear and tear.It should be mentioned that the loop at the distal end of the electrode wears out during use and may break, burn or melt.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the ifu, a suitable replacement device must be provided during an application.Olympus will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrabe 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16059345
• MDR Text Key: 306245321
• Report Number: 9610773-2022-00767
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000088470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female