MAUDE Adverse Event Report: ETHICON, INC. GYNECARE VERSAPOINT; COAGULATOR, CULDOSCOPIC (AND ACCESSORIES)

Catalog Number 00467

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/12/2015

Event Type  malfunction  

Event Description

Doctor was performing a hysteroscopic procedure to resect uterine tissue using the versapoint machine when the patient had a significant reflexive jerk.Doctor noticed this reaction corresponded to activation of the machine.Machine then went into error mode.The machine was turned off.The cord was unplugged.The machine was turned back on.The cord was plugged in.Connections were checked, and another attempt to resect tissue was made.The same results occurred after the second attempt.A decision was made to abort use of the versapoint.The machine was turned off and sequestered with the disposable tip, the foot pedal and the versapoint cord.The patient's vitals were assessed by the anesthesiologist.The patient's uterus was assessed by the doctor.No injury or adverse effects were noted by either.The fluid used for the hysteroscopy was assessed, which was normal saline.Per biomed: evaluated system.Repeatable failure with error 200 ref 15 (power generation shut shutdown fault(r)).Troubleshooting and consultation with technical support ((b)(4)) determined failure was related to disposable electrode ref 00467 lot ugy1508096.Console and reusable cable functioned correctly with a new electrode.

• Brand Name: GYNECARE VERSAPOINT
• Type of Device: COAGULATOR, CULDOSCOPIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON, INC.; rt. 22 west; p.o. box 151; somerville, NJ 08876
• MDR Report Key: 5270167
• MDR Text Key: 32765539
• Report Number: 5270167
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 00467
• Device Lot Number: UGY1508096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR