MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., STERILE, SINGLE USE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22355C

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/03/2023

Event Type  Injury  

Event Description

The customer reported to olympus the high frequency-resection electrode, 45° needle, single use distal end wire broke.The issue occurred during a diagnostic hysteroscopy and curettage.During the operation, device was cutting a neoplasm when the wire at the distal end broke, leading to increased bleeding and prolonged surgery time while the patient was under general anesthesia.There were no additional reports of patient impact.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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 suggest event occurred due to wear and tear.The loop at the distal end of the electrode wears out during use and may break, burn or melt.However, the root cause of the suggest event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., STERILE, SINGLE USE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• 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: 17451426
• MDR Text Key: 320315153
• Report Number: 9610773-2023-02129
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761030615
• UDI-Public: 14042761030615
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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: WA22355C
• Device Lot Number: 1000069806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2413-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other