MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE

Model Number A22201C

Device Problem Material Fragmentation (1261)

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

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that during an endometrial ablation using electrode resectoscope cutting loop 24fr 12 degree, the loop resection end broke off of the electrode inside the patient's uterus.The surgeon was able to retrieve the broken pieces and the electrode immediately with a pair of forceps.It was confirmed that all pieces were removed and confirmed all device pieces removed, through the scope already in use.The procedure was completed with a similar device.There was no patient harm reported.

Event Description

It was reported that the procedure was prolonged less than 10 minutes to open another device.The patient's anesthesia or sedation was not extended due to the device malfunction.The reported malfunction did not affect the outcome of the procedure or the condition of the patient.No medical intervention (i.E.Treatment outside the scope of the procedure) was required because of the reported problem.The device was inspected prior to use.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update with information received (b5), to provide an update to fields (d9, h3, and h4), and to provide a correction to the initial (g2).The device was evaluated by olympus, and it was confirmed that the cutting loop wire was broken off.Additionally, there were non-reportable (non-pae) defects noted.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the cause for the described issue is excessive force while using the affected device or wrong handling of the affected device.The loop on the distal end of the device can wear out during use and may break, burn or melt.However, the specific root of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17642311
• MDR Text Key: 322178182
• Report Number: 9610773-2023-02376
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201C
• Device Lot Number: 1000049799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FY24-EMEA-01
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention