FDA Adverse Event Injury Summary report: N

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

MDR report key: 2229415 · Received August 19, 2011

Report

Report Number: 3005278776-2011-00042
Event Type: Injury
Date Received: August 19, 2011
Date of Event: July 21, 2011
Report Date: July 21, 2011
Manufacturer: NITI SURGICAL SOLUTIONS LTD.
Product Code: FZP
PMA / PMN Number: K093661
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; (B)(4)) AND THE IMPORTER (B)(4), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO ITS SPECIFICATIONS. IT COULDN'T BE DETERMINED WHETHER THE EVENT IS RELATED TO THE COLONRING DEVICE AND IT MAY BE RELATED TO THE SURGICAL TECHNIQUE RATHER THAN TO THE DEVICE. A DISTAL TEAR MAY ALSO BE ASSOCIATED WITH A VIGOROUS APPLICATOR INSERTION. THE ADDITIONAL APPLICABLE 510 (K) IS: K062008.

Description of Event or Problem · 1

THE PT UNDERWENT AN OPEN SIGMOIDECTOMY PROCEDURE DUE TO COLON CANCER. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. ACCORDING TO THE REPORT, AFTER THE CREATION OF THE ANASTOMOSIS, A BUBBLE TEST WAS PERFORMED AND NEGATIVE LEAK TEST WAS NOTED. WHILE EXAMINING THE POSITION OF THE COLON AND THE ANASTOMOSIS, THE SURGEON NOTED THAT THERE WAS A SMALL SEROSAL TEAR ON THE DISTAL STUMP. FEW ABSORBABLE STITCHES WERE ADDED BY THE SURGEON ON THE COLON TISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)	IMPLANTABLE CLIP (FZP)	FZP	NITI SURGICAL SOLUTIONS LTD.	COLONRING (CAR27)	43271231

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention