MAUDE Adverse Event Report: COVIDIEN MEDTRONIC AUTOSUTURE PURSTRING

Lot Number P5J0J07X

Device Problems Misfire (2532); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2016

Event Type  malfunction  

Event Description

During an exploratory laparotomy, lysis of adhesion and esophagojejunostomy and a j-tube placement, the ethicon intraluminal stapler ils25 misfired and stapler purstring malfunctioned during the case.Thus, resulting in the surgeon changing method of procedure, hand sewn stitches to reinforce staples fired a second tie by a new eea anvil equipment and prolonging the surgery case.(b)(6).

• Brand Name: AUTOSUTURE PURSTRING
• Type of Device: AUTOSUTURE PURSTRING
• Manufacturer (Section D): COVIDIEN MEDTRONIC
• MDR Report Key: 5628329
• MDR Text Key: 44448951
• Report Number: MW5062040
• Device Sequence Number: 2
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: P5J0J07X
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR