MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number SIGPHANDLE

Device Problems Premature End-of-Life Indicator (1480); Failure to Advance (2524); Misfire (2532); Positioning Problem (3009)

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

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, at the first firing of rectum resection in a laparoscopic proctectomy, they set the powered stapling device and the cartridge.They checked the jaws and display screen with no problem.The surgeon started the firing; however, the knife stopped on the halfway.They pushed the center control button again; however, the knife did not advance.The display screen showed '0'.Replaced by a new cartridge and the firing was completed with no problem.The status of the patient was reported as no problem.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIGNIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7747220
• MDR Text Key: 116115472
• Report Number: 1219930-2018-04255
• Device Sequence Number: 0
• Product Code: GDW
• Reporter Country Code: JA
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGPHANDLE
• Device Catalogue Number: SIGPHANDLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1