MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA ADAPTER STANDARD; STAPLE, IMPLANTABLE

Model Number EGIAADAPT

Device Problem Unintended Arm Motion (1033)

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

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a low anterior resection, an idrive and an egia60amt were prepared.The jaws were articulated and grasped the tissue.However, the device did not enter firing mode when the green button was pressed.Subsequently, the jaws returned to the straight position on their own.A new adapter was used and worked properly.It is unknown if buttress material was used.The last known patient status is good.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one adapter standard.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device by both pmv and engineering.The reported condition for this incident was uncontrolled articulation and unable to enter firing mode during a low anterior resection procedure.The investigation was unable to replicate the reported conditions.However, further investigation found cracked solder joints between the reload detect switch and the (b)(4) board.This can lead to intermittent occurrences of the uncontrolled articulation condition.A malfunctioning switch is the result of several variables including: improper solder operation at the vendor location, improper assembly of the sealed switch to the (b)(4) board at the vendor location, and/or improper soldering during assembly.The reported condition of unable to enter firing mode could not be investigated because the idrive handle was not returned.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: ENDO GIA ADAPTER STANDARD
• 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 ; 2034925267
• MDR Report Key: 5156266
• MDR Text Key: 28844030
• Report Number: 1219930-2015-00892
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121510
• 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: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Model Number: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Device Lot Number: N5A1037LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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