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 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been received.A supplemental report will be sent upon completion of investigation if device is received.

Event Description

According to the reporter, during a laparoscopic sigmoidectomy, the jaws of the reload articulated on their own.In an effort to correct the problem, the reload was re-attached to the adapter; but reload symbol did not turn on.When idrive was reassembled from scratch, the device worked fine.There was no injury or adverse event reported.

Manufacturer Narrative

(b)(4).Device has been received but evaluation not yet begun.A supplemental report will be sent upon completion of investigation.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) examined one adapter returned by the account.This evaluation was based on technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and pmv and engineering evaluations of the returned devices.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 34 autoclave cycles for the adapter.The user interface features on the adapter were found to function properly.A pmv representative handle was used for testing.The adapter was inserted onto the handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.A reload from our inventory was inserted onto the adapter and the system initially did not recognize the presence of a reload.Further investigation of the returned adapter noted that the system would intermittently not recognize the presence of the reload when the adapter.Additionally, the system was intermittently able to regain reload recognition and articulated during recalibration.The adapter was disassembled for examination of internal components.The solder connections were examined and determined to be cracked.The cracked solder joint condition prevented the switch from making a consistent electrical connection with the system in all rotational orientations.It is when a lost recognition is regained that the system begins a calibration cycle which includes articulation of the reload.Based on these observations, it was concluded that the reload articulated on its own and did not recognize the reload due to cracked solder joints.A product enhancement has been initiated for the failure mode of uncontrolled articulation.The file will be closed as an assembly error.Should new information become available, the file will be re-opened and reassessed at that time.

• 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: s murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5518009
• MDR Text Key: 40933947
• Report Number: 1219930-2016-00254
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2016

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: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Device Lot Number: N5D1218LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2016; 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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