MAUDE Adverse Event Report: ETHICON INC. GYNECARE X-TRACT MOTOR DRIVE UNIT; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number MD0100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2014

Event Type  malfunction  

Manufacturer Narrative

Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.The device performed according to specification.

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2014.During the procedure, the device would not activate the disposable.A second disposable was tried with the same result.Another like device was used to complete the procedure with no adverse patient consequences.

Manufacturer Narrative

(b)(4) - insufficient drive of disposable.Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: GYNECARE X-TRACT MOTOR DRIVE UNIT
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - HEI; 4801 n 63rd st; boulder CO 80301
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3731230
• MDR Text Key: 11956770
• Report Number: 2210968-2014-04380
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993801
• 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,Followup
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD0100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2014
• 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