MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT II ELECTROSURGICAL GENERATOR, NON-STERILE, REUSABLE; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Model Number WA47790A

Device Problems Flare or Flash (2942); Excessive Heating (4030)

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

Event Date 03/13/2023

Event Type  Injury  

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.

Event Description

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 versapoint ii electrosurgical generator, non-sterile, reusable.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: a3 and b5.

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

Additional information was obtained regarding section d/device information.The model and serial numbers were obtained, as the original report was incorrect.After further review, this device is not an olympus generator, but rather another manufacturers.Olympus does not sell or manufacture this device.No further device reporting will be sent.

• Brand Name: VERSAPOINT II ELECTROSURGICAL GENERATOR, NON-STERILE, REUSABLE
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (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: 16743189
• MDR Text Key: 313331363
• Report Number: 9610773-2023-01038
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 04042761086592
• UDI-Public: 04042761086592
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2023

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: WA47790A
• Device Catalogue Number: WA47790A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 04/19/2023; 05/05/2023
• Supplement Dates FDA Received: 04/19/2023; 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• 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 GY1820767.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female