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

Model Number SIGPHANDLE

Device Problems No Display/Image (1183); Overheating of Device (1437); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one signia powered handle.Analysis of the system logs showed no abnormalities in oled functionality.The log files also indicate that prior to the last firing in the field there were multiple unknown continuous resets.The logs showed signs of the handle heating up, but the temperatures that the handle experienced were within specifications.The rear housing of the device was removed and damage was noted to the 44-pin flex cable on the ground pins where it connects to the motor board.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.The root cause of the observed damage to the flex cable was determined to be a result of a manufacturing activity.Damage to the ground pins can result in a continuous reset due to an intermittent connection.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to laparoscopic assisted distal gastrectomy, the handle did not turn on.In addition, the handle was considerably hotter, and the calibration sound was heard, but the other tones were not heard.When the handle was attempted to be inserted in the shell once, there was no response, so a different handle and a different shell was used to continue the procedure.There was no patient involvement.

• 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: 9253205
• MDR Text Key: 164273205
• Report Number: 1219930-2019-06120
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543782
• UDI-Public: 10884521543782
• Combination Product (y/n): N
• 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
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGPHANDLE
• Device Catalogue Number: SIGPHANDLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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