MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG SIGNIA; STAPLE, IMPLANTABLE

Model Number SIGTRS45AXT

Device Problems Misfire (2532); Separation Failure (2547); Failure to Form Staple (2579)

Patient Problem Tissue Damage (2104)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: occurred during a lobectomy.The surgeon felt he had fully fired the reload, but observation of the reload indicated that the buttress material was not fully cut until the end and there was 1/4 of the staples that did not deploy.The staple line was incomplete.Further stapling was necessary due to the buttress material still being attached to the new staple line and the reload.An attempt was made to pull the two apart which caused tissue damage to the lung.Additional staple reloads were used to secure air leak.The surgeon noted that the patient¿s lungs were in very poor condition and the tissue was very friable.However, it was unclear if this was related to the device issue.The report indicated the patient is alive but no further information was provided.

• Brand Name: SIGNIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7119111
• MDR Text Key: 94924989
• Report Number: 1219930-2017-09952
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: SIGTRS45AXT
• Device Catalogue Number: SIGTRS45AXT
• Device Lot Number: N7H0729X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/14/2017
• Date Device Manufactured: 08/17/2017
• 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