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

Model Number WA22302D

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the sling at the front of the hf-resection electrode broke off in the uterus during the first coagulation and they were unable to find it again.No patient harm was reported.Additional information has been requested but not yet provided.

Manufacturer Narrative

D1: hf-resection electrode, loop, 24 fr., 0.2 wire, medium, 12°, sterile, single use, 12 pcs., for turis the device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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 information received through follow up.Updated fields include the following: b2, b3, d4, d9, d10, e1, h3, h4, h6, and h10.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The evaluation confirmed the following: the electrode loop had burned down to the electrode fork, the insulating tubes were thermally stressed and the electrode fork was deformed.The burning down of the electrode wire was preceded by a break or deformation of the loop.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 the reported event occurred due to inappropriate/unsuited user handling.However, a specific root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received: it was reported that during a therapeutic hysteroscopy polyp resection procedure the broken part was detectable in the ct scan on october 24, but was no longer detectable in the fluoroscopy during the follow-up operation.The device malfunction was detected in the patient's uterus during the initial application.The user thinks that the loop had spontaneously expulsed vaginally from the posterior vaginal vault.The procedure was completed with the use of a similar device.However, the procedure was prolonged by approx.30 min, as the snare had to be searched for in the cavum, the vagina, and the adjacent materials during the operation.The clinical condition during this time was always stable and has no long-term consequences for the patient.Additionally, due to the broken sling, the patient required imaging (ct) and a second procedure to visualize and remove the sling.Ultimately, the snare could no longer be visualized during the second procedure.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ELECTRODE
• 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: 18193494
• MDR Text Key: 328883729
• Report Number: 9610773-2023-03375
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Lot Number: 1000110333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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
• Treatment: OLYMPUS CAMERA; OLYMPUS ESG-400; OLYMPUS FOOT SWITCH WB 50402W; OLYMPUS HYSTEROFLOWIL; OLYMPUS VISERA ELITE II OTV-S200
• Patient Outcome(s): Required Intervention; Other