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

Catalog Number 00482

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Edema (1820); Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 04/21/2014

Event Type  Injury  

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It reported that a patient underwent an electrosurgical procedure on (b)(6) 2014.During the procedure, an unknown error with the device occured while using glycine and not saline.The patient experienced massive edema.The procedure was not completed.The patient was extubated and transferred to icu after the procedure.The current condition of the patient was reported as stable.It was opined by the reporter that it was not due to the device.Additional information has been requested.

Manufacturer Narrative

(b)(4).Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• 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 015
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 OLT; UK CF3 OLT
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3865905
• MDR Text Key: 18458743
• Report Number: 2210968-2014-07403
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2014

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
• Device Catalogue Number: 00482
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 06/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention