FDA Adverse Event Malfunction Summary report: N

GYNECARE MORCELLEX TISSUE MORCELLATOR

MDR report key: 3900262 · Received June 27, 2014

Report

Report Number: 2210968-2014-08365
Event Type: Malfunction
Date Received: June 27, 2014
Date of Event: June 2, 2014
Report Date: June 10, 2014
Manufacturer: ETHICON INC.
Product Code: HET
PMA / PMN Number: K100280
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION: THE ACTUAL DEVICE WITH A DAMAGED TYVEK LID, WITHOUT A CASE OR CARTON, WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, THE LID HAS A PUNCTURE IN IT. IT APPEARED THAT A FOREIGN BLUNT OBJECT LEFT A DRAG MARK JUST ABOVE THE HOLE WHERE IT WENT INTO THE BLISTER. THE CONTENTS WERE NOT DISTURBED AND THERE WERE NO VISIBLE SIGNS OF ANY FRAGMENTS OR OTHER DAMAGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Additional Manufacturer Narrative · 1

(B)(4). 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2014. PRIOR TO OPENING THE DEVICE AND REMOVING IT FROM THE PACKAGE, A 1 TO 2 CM HOLE IN THE MIDDLE OF THE PACKAGE WAS FOUND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
376374	GYNECARE MORCELLEX TISSUE MORCELLATOR	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	HET	ETHICON INC.	UNK	MT218946

Patients

Seq	Age	Sex	Outcome	Treatment
1