MAUDE Adverse Event Report: ETHICON, INC. GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC

Catalog Number MX0100

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 03/27/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Conclusion: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

Conclusion: the actual device involved in this event was returned for evaluation. The device was visually and functionally evaluated. The blade failed to rotate during the evaluation; it is likely that the accumulation of blood, body fluids, and tissue prevented the device from continuing to operate as intended.

Event Description

It was reported that a patient underwent a laparoscopic oophorectomy on (b)(6) 2013. During the procedure, the device worked properly at first. After that, the device did not activate properly during use. Another like device was used to complete the procedure with no adverse patient consequences.

• Type of Device: LAPAROSCOPE, GYNECOLOGIC
• Manufacturer (Section D): ETHICON, INC.; route 22 west; po box 151; somerville NJ 08876
• Manufacturer (Section G): THE MEDTECH GROUP INC.; 6 century road; south plainfield NJ 07080
• Manufacturer Contact: kathy rice ; 4545 creek road; mail location 120; cincinnati, OH 45242 ; 5133373299
• MDR Report Key: 3070318
• MDR Text Key: 10715669
• Report Number: 2210968-2013-04206
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2013

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: MX0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/27/2013
• Event Location: Hospital
• Date Manufacturer Received: 06/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial