MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT RESECTOSCOPIC SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2016 and the electrosurgical device was used.Following the procedure, the patient developed embolism.No further information is available.

Manufacturer Narrative

Additional information was requested and the following was obtained: date and name of initial surgical procedure: - hysteroscopic myomectomy.The diagnosis and indication for the initial surgical procedure - myomectomy.What were current symptoms following the index surgical procedure - onset date - embolism associated with use of the system during hysteroscopic myomectomy procedures.Product serial number: bipolar loop electrode ¿ (b)(4).Will the product be returned - no.Did the embolism occur during the procedure or post procedure - post procedure.What is the patients current status - stable.

• Brand Name: VERSAPOINT RESECTOSCOPIC SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 O LT; UK CF3 OLT
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6138277
• MDR Text Key: 61228430
• Report Number: 2210968-2016-15236
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention