MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PURSTRING DEVICE; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN PURSTRING DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Abscess (1690); Peritonitis (2252); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

Title: the small height of an anastomotic colonic doughnut is an independent risk factor of anastomotic leakage following colorectal resection: results of a prospective study on 154 consecutive cases.Source: int j colorectal dis (2017) 32(5):699707 doi 10.1007/s00384-017-2769-9.Epub 2017 jan 26.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature report, the aim of this prospective study was to assess the influence of morphological characteristics of anastomotic doughnuts on the risk of anastomotic leakage (al) after double-stapled colorectal anastomosis.This single-center prospective study enrolled all patients undergoing double-stapled colorectal anastomosis between december 2012 and december 2015.Maximal diameter and minimal and maximal heights and widths of both colonic and rectal doughnuts were measured by surgeons in the operating room.In patients undergoing laparoscopic surgery for colorectal cancer, a 5-cm incision in the right iliac fossa was used for colonic purse placement.The technique for suture of the purse was either hand-sewn or using a purse string device.Post-operative complications included: 17 patients had anastomotic leakage, 12 patients had intra-abdominal abscess, 3 patients had peritonitis, 13 patients had wound infection, 18 patients had ileus, and 13 patients had re-operation.

• Brand Name: UNKNOWN PURSTRING DEVICE
• Type of Device: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12675261
• MDR Text Key: 277749042
• Report Number: 2647580-2021-03554
• Device Sequence Number: 1
• Product Code: GDJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PURSTRING DEVICE
• Device Catalogue Number: UNKNOWN PURSTRING DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR