FDA Adverse Event Malfunction Summary report: N

GYNECARE MORCELLEX TISSUE MORCELLATOR

MDR report key: 3252066 · Received July 29, 2013

Report

Report Number: 2210968-2013-14848
Event Type: Malfunction
Date Received: July 29, 2013
Date of Event: July 9, 2013
Report Date: July 11, 2013
Manufacturer: ETHICON INC.
Product Code: HET
PMA / PMN Number: K100280
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

Additional Manufacturer Narrative · 1

(B)(4). 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): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE BLADE FAILED TO ROTATE, AND THE DRIVE CABLE KEPT TWISTING DURING THE EVALUATION. FURTHERMORE, IT IS LIKELY THAT THE ACCUMULATION OF TISSUE DURING THE PROCEDURE PREVENTED THE BLADE FROM CONTINUING TO ROTATE AS INTENDED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE CABLE WAS JUMPING FROM START TO END. THE BLADE TURNED BUT NOT IN A STEADY ROTATION, IT JERKED. THE PROCEDURE WAS COMPLETED WITH THE DEVICE AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352974	GYNECARE MORCELLEX TISSUE MORCELLATOR	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	HET	ETHICON INC.	UNK	MT216886

Patients

Seq	Age	Sex	Outcome	Treatment
1