FDA Adverse Event Injury Summary report: N

COMPRESSION ANASTOMOSIS RING (CAR)

MDR report key: 1327635 · Received September 11, 2008

Report

Report Number
3006298502-2008-00001
Event Type
Injury
Date Received
September 11, 2008
Date of Event
May 9, 2008
Report Date
September 11, 2008
Manufacturer
NITI SURGICAL SOLUTIONS LTD
Product Code
LNN
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
MO, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PATIENT UNDERWENT AN OPEN SIGMOID RESECTION FOR DIVERTICULITIS, UTILIZING DOUBLE PURSE-STRING TECHNIQUE WITH THE ANVIL PLACED PROXIMALLY. FORMING THE PURSE-STRING, AND THE TISSUE REMAINED EXCESSIVE (ALMOST 8-9MM). THE CAR WAS INTRODUCED FROM BELOW, AND ANOTHER PURSE-STRING SIMILAR FORMED OVER THE TROCAR, AGAIN WITH SOMEWHAT EXCESSIVE TISSUE. WHEN THE ANASTOMOSIS WAS FORMED, THERE APPEARED TO BE A SMALL AREA BETWEEN 9 AND 12 O'CLOCK IN THE ANASTOMOSIS THROUGH WHICH A SMALL LIP OF BOWEL EDGE APPEARED TO PROTRUDE. "DOUGHNUTS" WERE LARGE AND INTACT. ON POD 4, THE PATIENT SAID SHE HAD NIGHT SWEATS, SHE WAS OTHERWISE ASYMPTOMATIC. ON POD 5, SHE STILL HAD NIGHT SWEATS AND LOOKED UNCOMFORTABLE, SHE HAD PERITONEAL SIGNS, NORMAL WBC, NORMAL VITALS SINGLE TEMP 38.5 GOOD UOP. SHE WAS TAKEN TO THE OR. FOUND PUSS AND A LEAK ON THE RIGHT LATERAL ASPECT OF THE ANASTOMOSIS ABOUT THE SIZE OF A PENCIL. THE LEAK WAS IN THE AREA BETWEEN 9 AND 12 O'CLOCK WHERE THE SMALL LIP OF TISSUE PROTRUSION HAD BEEN NOTICED. THE TISSUE WAS STILL GOOD SO THE HOLE WAS OVER SEWN EASILY AND A DIVERTING LOOP ILEOSTOMY WAS DONE. SHE WAS IN THE UNIT FOR 2 (POD 7) DAYS AND ON DAY 5 (POD 11) HAD A STOOL, HAS HAD NO PERITONEAL SIGNS, IS FEELING BETTER WAS DISCHARGED BY FRIDAY (POD 13). SUMMARY: THE SMALL LEAK AREA WAS OVERSEWN AND THE PATIENT MADE AN UNEVENTFUL RECOVERY.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 62 YR Hospitalization RE-OPERATION FOR MINOR LEAK THAT WAS OVERSAWN