MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number WA22707S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

As reported, the electrosurgical electrode loop was completely detached, fell off in the patient and was never retrieved.The issue occurred during therapeutic "rtuv" procedure.The intended procedure was completed.The device was discarded.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been 1 year since the subject device was manufactured.Based on the results of the investigation, the reported issue (distal end detachment/fall into patient) was likely due to wear and tear of the device.The loop at the distal end of the electrode may wear during use and can break, melt, or burn.This supplemental report includes a correction to b5 and g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that no medical interventions were conducted to locate the broken device piece.It was confirmed that there was no patient harm.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, 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, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18741834
• MDR Text Key: 335810991
• Report Number: 9610773-2024-00482
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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: WA22707S
• Device Lot Number: 1000118109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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
• Patient Outcome(s): Other