MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON SIGNIA LINEAR ADAPTER XL; STAPLE, IMPLANTABLE

Model Number SIGADAPTXL

Device Problem Unintended Arm Motion (1033)

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

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has been received but evaluation is pending.A supplemental report will be sent upon completion of investigation.

Event Description

According to the reporter, during a sleeve gastrectomy, the device was set up and on the first firing with one of the black reloads it worked fine.The second reload was put on the device and as the surgeon was articulating and clamping down on the tissue, the unit was de-articulating and straightening out.The surgeon was unable to alleviate issue.They tried again with another reload from the same lot and the same issue occurred.There was no injury to the patient.The surgery had to be completed with a different stapler.There was no delay in surgical time of more than 30 minutes.There was no extension for incision for incision by more than one inch.No device fragment fell into the patient.No unanticipated blood loss of 500ccs or more.There was no unanticipated tissue loss.Additional information has been requested but not yet received.A supplemental report will be submitted upon receipt of new information.

• Brand Name: SIGNIA LINEAR ADAPTER XL
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6144655
• MDR Text Key: 61444779
• Report Number: 1219930-2016-01284
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Device Lot Number: C16ACK0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: RELOAD, POWERED HANDLE