MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; WA47787A

Model Number	WA47787A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the during a gynecological procedure-hysteroscopic endoscopy for myoma, the electrode was loosened and detached that fell into the patient's uterine cavity.Reportedly, the sling did not slide into the trocar and liquid supply stopped during combustion.The gynecologist could not find the part of device inside patient and thus scoped the patient (without a sleeve into the vaginal cavity) and searched for the device without any success, wherein there was no flow.Also, an x-ray was undertaken, the sling was visible inside the uterine cavity.The procedure was delayed by 20 minutes and no additional anesthesia was required.A week later, the patient came in for an outpatient hysteroscopy for retrieval of device.Reportedly the patient developed uterine infection on (b)(6) 2024, and patient had fever, the c-reactive protein was elevated, blood and body fluids were cultured.Cultures were negative, and patient had low abdominal pain.Infection was confirmed and patient received the following treatment.(b)(6) 2024 iv zinacef 1.5g 1x3 j, iv metronidazole 400mg 1x3.(b)(6) 2024 kefeksin 750 x3, po metronidazole (flagyl) 400 x3.(b)(6) 2024 kefeksin 500mg x3, po metronidazole (flagyl) 400mg x3.The patient displayed signs and symptoms of infection.No prophylactic antibiotics were administered.A new procedure was undertaken and sling tip was removed successfully on 26aug2024.The infection subsided with anitibiotics and patient feels okay.Additionally, it was reported the device was misused during the procedure, wherein the sling was used during the procedure without the outer sleeve and the tip of the sling was detached and remained in the patient.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide a correction to field g2.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, the subject device was not returned, and the specific root cause of the reported event could not be identified with the information received.Olympus will continue to monitor field performance for this device.

• Brand Name: VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING
• Common Device Name: WA47787A
• 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: 20599167
• Report Number: 9610773-2024-02643
• Device Sequence Number: 8803965
• Product Code: HIN
• UDI-Device Identifier: 14042761086261
• UDI-Public: 14042761086261
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K111751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: WA47787A
• Device Lot Number: U2307069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown