FDA Adverse Event Injury Summary report: N

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

MDR report key: 2245641 · Received September 2, 2011

Report

Report Number: 3005278776-2011-00049
Event Type: Injury
Date Received: September 2, 2011
Date of Event: August 2, 2011
Report Date: August 4, 2011
Manufacturer: NITI MEDICAL TECHNOLOGIES LTD.
Product Code: FZP
PMA / PMN Number: K062008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (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 EVAL. HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECS. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATION OF COLORECTAL ANASTOMOTIC PROCEDURES WITH NO RELATION TO THE METHOD USED FOR THE CREATION OF THE ANASTOMOSIS. THE CURRENT CUMULATIVE LEAK RATE ASSOCIATED WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR OTHER METHODS. THE APPLICABLE 510(K) IS: K093661.

Description of Event or Problem · 1

THE PT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY DUE TO DIVERTICULITIS. CYSTOSCOPY WITH BILATERAL URETERAL STENT PLACEMENT WAS ALSO DONE DURING THE SAME PROCEDURE. ON POD 5, THE PT COMPLAINED OF ABDOMINAL PAIN AND X-RAY REVEALED FREE AIR AND FLUID IN THE ABDOMEN. ANASTOMOTIC DEHISCENCE WAS FOUND UPON RE-EXPLORATION. THE RING WAS REMOVED AND DIVERTING COLOSTOMY AND HARTMAN'S WERE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)	IMPLANTABLE CIP	FZP	NITI MEDICAL TECHNOLOGIES LTD.	COLONRING (CAR27)	43271244

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention