COMPRESSION ANASTOMOSIS RING (CAR) 435110-27

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-09-11 for COMPRESSION ANASTOMOSIS RING (CAR) 435110-27 manufactured by Niti Surgical Solutions Ltd.

Event Text Entries

[1031795] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3006298502-2008-00001
• MDR Report Key: 1327635
• Report Source: 99
• Date Received: 2008-09-11
• Date of Report: 2008-09-11
• Date of Event: 2008-05-09
• Date Facility Aware: 2008-05-16
• Report Date: 2008-09-11
• Date Reported to FDA: 2008-07-22
• Date Reported to Mfgr: 2008-05-16
• Date Added to Maude: 2010-06-12
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COMPRESSION ANASTOMOSIS RING (CAR)
• Generic Name: CAR 27
• Product Code: LNN
• Date Received: 2008-09-11
• Catalog Number: 435110-27
• ID Number: REF EC 27
• Device Expiration Date: 2011-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NITI SURGICAL SOLUTIONS LTD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2008-09-11