MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING; HYSTEROSCOPE (AND ACCESSORIES)

Model Number WA47786A

Device Problem Flare or Flash (2942)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

Hold sac 4/21 a user facility reported to olympus, that while using the versapoint ii electrosurgical generator, non-sterile, reusable for a myomectomy.Four (4) loops were opened for the case.The first loop burned through while "activated".The surgeon managed to get the metal part out (presumably out of the body) by curetting it out and washing it out with saline under pressure.Three other loops were opened, and all burned through the center of the loop before attempting to use the loop to cut.A new generator was brought in and the case was finished with a loop, without any further problems.The first generator had been serviced 3 weeks prior to the case.However, when the technician went out to the facility the day after the issues were noted, the generator was on the maximum setting of 200, which was past the default setting of 170.It was stated, that the staff had not changed any settings and they use the default setting.Additional information has been requested.This event requires 5 reports: (b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (first loop).(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (second loop).(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (third loop).(b)(6) is for a versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting (fourth loop).(b)(6) is for the versapoint ii electrosurgical generator, non-sterile, reusable.This mdr is for the third versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.

Event Description

Additional information was obtained.The indication for the myomectomy was a large myoma found on scan.When asked how long the delay was, the user facility stated that the operation took a total of 145 minutes.They were unable to say exactly how long the delay was, but that it was probably about 3 minutes per each loop exchange.It was also stated that since it was a large fibroid, it did a long time to remove it.The anesthesiologist kept the patient sedated as per normal.The patient had no adverse effects and went home the next morning.

Manufacturer Narrative

Updated fields: d9, h3, h4, h6, h10.Corrected fields: d4 (lot number), d10 (lot numbers were inverted), e1/e2/e3 (information was inadvertently omitted).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection and the customer's complaint was confirmed.The loop at the distal end was found broken.No electrical or functional testing was conducted.The condition of the fracture face of the device suggests a brittle failure.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, (per capa cap-100101), the root cause for this issue is likely due to a weakness in the current material strength and/or ductility.Olympus will continue to monitor field performance for this device.

• Brand Name: VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 16743483
• MDR Text Key: 313717535
• Report Number: 9610773-2023-01041
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 14042761086254
• UDI-Public: 14042761086254
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA47786A
• Device Catalogue Number: WA47786A
• Device Lot Number: U2206120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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: VERSAPOINT BIPOLAR ELECTRODE LOOP ¿ LOT GY1820767; VERSAPOINT BIPOLAR ELECTRODE LOOP ¿ LOT GY1820767; VERSAPOINT BIPOLAR ELECTRODE LOOP ¿ LOT GY1820767; VERSAPOINT BIPOLAR ELECTRODE LOOP ¿ LOT U2206120; VERSAPOINT BIPOLAR ELECTRODE LOOP ¿ LOT U2206120; VERSAPOINT BIPOLAR ELECTRODE LOOP ¿ LOT U2206120; VERSAPOINT II ELECTROSURG. GENERATOR¿SN (B)(6); VERSAPOINT II ELECTROSURG. GENERATOR¿SN (B)(6)
• Patient Sex: Female