FDA Adverse Event Injury Summary report: N

COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

MDR report key: 2231122 · Received August 26, 2011

Report

Report Number: 3005278776-2011-00047
Event Type: Injury
Date Received: August 26, 2011
Date of Event: August 25, 2011
Report Date: July 27, 2011
Manufacturer: NITI SURGICAL SOLUTIONS LTD.
Product Code: FZP
PMA / PMN Number: K093661
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
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 RETURNED FOR EVALUATION. A REVIEW OF THE PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO ITS SPECIFICATIONS. USING THE DEVICE WITHOUT LOADING THE RING ON THE APPLICATOR IS CLEARLY A USER ERROR AND NOT A DEVICE FAILURE. LOADING THE APPLICATOR IS A CLEAR STEP IN DEVICE OPERATION AND IS CLEARLY DESCRIBED AND DEMONSTRATED IN THE DEVICE INSTRUCTIONS FOR USE AND TRAINING. IT SHOULD BE NOTED THAT THIS IS THE FIRST THAT SUCH OCCURRENCE IS REPORTED TO US. THE APPLICABLE 510(K)S ARE: K093661 AND K062008.

Description of Event or Problem · 1

THE COLONRING DEVICE WAS USED FOR THE CREATION OF COLORECTAL ANASTOMOSIS FOLLOWING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE. IT WAS REPORTED THAT THE RING WAS NOT LOADED ONTO THE DEVICE AND WAS USED. THE ANVIL WAS RESECTED FROM THE PROXIMAL STUMP AND ANOTHER COLORING DEVICE WAS OPENED AND USED.

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)

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Required Intervention