COMPRESSION ANASTOMOSIS RING (CAR 27)

Report

Report Number: 3005278776-2010-00119
Event Type: Injury
Date Received: August 10, 2010
Date of Event: January 1, 2010
Report Date: June 13, 2010
Manufacturer: NITI SURGICAL SOLUTIONS LTD.
Product Code: FZP
PMA / PMN Number: K062008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; 3005278776) 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 AND NO ADDITIONAL INFORMATION IS YET AVAILABLE REGARDING THE RING OR THE DEVICE. NO CONCLUSIONS COULD BE DRAWN IN THE MEANWHILE, BASED ON THE AVAILABLE INFORMATION. COMPLICATIONS SUCH AS BLEEDING AND STRICTURES ARE ANTICIPATED COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES. IN THIS CASE, THE SURGEON, ALTHOUGH COULD NOT CONCLUDE ON THE EXACT CAUSE OF THE STRICTURE, IMPLIED THAT THE EVENT IS A PATIENT, RATHER THAN DEVICE, RELATED ISSUE.

Description of Event or Problem · 1

A PATIENT WHO UNDERWENT COLORECTAL SURGERY IN WHICH THE ANASTOMOSIS WAS CREATED WITH THE CAR DEVICE CONTINUED TO HAVE RECURRENT BLEEDING FOR ABOUT 3 MONTHS. RECTOSCOPY REVEALED ANASTOMOSIS WITH COPIOUS GRANULATION TISSUE THAT REQUIRED LAPAROSCOPIC REVISION DUE TO ONGOING BLEEDING. AT SURGERY, THERE WAS NO APPEARANCE OF ISCHEMIA AND THE ANASTOMOSIS WAS REDONE WITH STAPLER. WHEN THE PATIENT WAS RETURNED BACK FOR FOLLOW UP, THE SURGEON SAW THAT SHE HAD "EVEN MORE" STRUCTURING WITH THE STAPLER THAN WITH THE RING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COMPRESSION ANASTOMOSIS RING (CAR 27)	IMPLANTABLE CLIP (FZP)	FZP	NITI SURGICAL SOLUTIONS LTD.	CAR 27

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention