MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR.

Model Number WA22507D

Device Problem Material Disintegration (1177)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During a polypectomy procedure, the patient's endometrial tissue appeared loose and the high frequency resection electrode loop was used mechanically to remove the tissue.During one of the contacts, the electrode/loop reportedly bent backwards and when the energy was activated a portion of the loop broke with its central part being vaporized.Some fragments fell into the patient.Hysteroscopy was continued in order to explore the patient cavity and ensure no fragments remained inside the patient.The procedure was completed without major problems.No death or serious injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h4, h6 and h10.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The cause of the reported issue is attributed to wear and tear.Additional information: it should be noted that the loop at the distal end of the electrode wears out during use and may break, burn or melt.The legal manufacturer will continue to monitor complaints for this device.

Event Description

During the middle of a polypectomy procedure, the high frequency resection electrode loop was used mechanically to remove the tissue.The patient's endometrial tissue appeared loose and for this reason more mechanical force was used to avoid damage to the tissue.During one of the contacts, the electrode/loop reportedly bent backwards and when the energy was activated a portion of the loop broke.No fragment fell into the patient as the central portion of the loop was vaporized.Hysteroscopy was continued in order to explore the patient cavity and ensure no fragments remained inside the patient.Another high frequency resection electrode loop was used to complete the procedure.No unexpected bleeding was observed and there was no delay in the procedure.No death or serious injury was reported.The patient is fine with no harm reported to date.The item was not inspected prior to use and the subject device was discarded by the user facility following the procedure.

Manufacturer Narrative

This supplemental report was submitted to provide additional information regarding the reported event a correction (to b5) update the following sections: a3, g3, g6, h2, h6 and h10.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.
• Type of Device: HF-RESECTION ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11924736
• MDR Text Key: 268137917
• Report Number: 9610773-2021-00151
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22507D
• Device Catalogue Number: WA22507D
• Device Lot Number: 1000058260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1