MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 1; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problems Unintended Arm Motion (1033); Calibration Error (1078)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during a hepatectomy, when the reload was attached to the adapter, the reload indicator did not turn on.At the tenth attempt, the reload was attached.When the surgeon approached the tissue, the reload jaws articulated on their own and struck the liver, which caused bleeding.The device appeared to repeat its self check, and the reload indicator was flashing at this time.Another device was opened to correct the problem.It is unknown if reinforcement material was used.There was no unanticipated tissue loss.There was no irreversible tissue damage.There was no unanticipated extension for the incision more than one inch.There was no unanticipated blood loss of more than 500cc.Surgery time was not delayed by more than 30 minutes.

Event Description

The tip of the reload hit the liver and the liver "had a crash-like damage 1cm x 1cm." since the damage to the liver was irreversible, the surgeon used cautery knife to stop the bleeding.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) examined one adapter standard and one battery pack 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.No visual abnormalities were noted for the battery.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 13 autoclave cycles for the adapter.The user interface features were found to function properly.Since the clinical handle was not returned, a handle from our inventory was used for all functional testing.The subject battery was inserted into this handle and calibrated without issue.The adapter was inserted onto the pmv 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 engineering investigation of the returned adapter noted that the system would intermittently not recognize the presence of the reload when the adapter.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.This is considered to be what the customer experienced during the loading process.Based on these observations, it was concluded that the reload articulated on its own as reported by the customer due to cracked solder joints.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: IDRIVE ULTRA POWERED HANDLE 1
• 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: 5659251
• MDR Text Key: 45302715
• Report Number: 1219930-2016-00443
• 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: Initial,Followup,Followup
• Report Date: 04/25/2016

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 Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5K1021LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/27/2016; 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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
• Patient Outcome(s): Required Intervention