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 08/12/2013

Event Type  malfunction  

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2013.During the procedure, the motor speeds could not be adjusted.There were no adverse patient consequences.

Manufacturer Narrative

(b)(4).Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, the motor assembly needed to be replaced to address the variable speeds.The coupler, flexible with bushing needed to be replaced because the coupler had been modified in a manner that made it non-conforming.In addition, a review of the device manufacturing records was conducted and the device met all finished goods release criteria.

• 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): HEI, INC.; 4801 north 63rd. st; boulder CO 80301
• Manufacturer Contact: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 3644508
• MDR Text Key: 17930075
• Report Number: 2210968-2014-01736
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K993801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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