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

Model Number IDRVULTRA1

Device Problem Unintended Arm Motion (1033)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a lap assisted distal gastrectomy, the nurse closed the jaws before the device was inserted into the cavity; however, status indicator did not show a solid green, the jaws articulated on its own and the device stopped working.A new device was used to complete the procedure.No injury or adverse event was reported.Ri-staple reload? tri-staple reload lot#: asku.If the customer cannot supply the specific lot number, what lot numbers were in inventory at the time of this incident? lot#: asku.Please provide the udi number (barcode) for the subject device(s).(pdf example is attached.Udi number is typically found in the area of the red box shown) not available.Please confirm that product will be returned for investigation.Only idrive will be returned for investigation.Was any reinforcement material used in conjunction with the stapling device? not available.If yes, what was the brand of the reinforcement material used? what was the item code and lot/serial number of the reinforcement material? was surgical time extended by more than 30 minutes due to the product problem? no.Was any adverse event reported as a result of any delay in surgery? (i.E.An extension of the hospital stay, infection, etc.?) no.What is last known patient status? good.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one handle opened by the account.The eeprom (electrically erasable programmable read only memory) was uploaded and indicated 23 autoclave cycles for the handle.The quick connect was functionally depressed numerous times and displayed no hang-ups or abnormalities.The articulation, rotation, close/fire, open and push to fire buttons and knobs were twisted and depressed all showing full functionality.Since the clinical battery, adapter, and reload were not returned, pmv representative ones were utilized for all functional testing.A pmv battery pack was loaded into the device.The device powered up properly and system calibration was successful indicated by the steady green light above the handle symbol.All five white status lights illuminated indicating more than 15 surgeries remaining on the handle.A pmv adapter was inserted onto the handle and calibrated without issue.A pmv reload was inserted onto the adapter and the reload detect led immediately started flashing as intended, indicating that the software recognized the presence of a reload.The reload was closed and then opened to change the flashing green reload detect led to a solid green state.The adapter was rotated in increments of forty five degrees and fully articulated left and right each time, and the device recognized the reload the entire time.The pmv reload was then cycled without hesitation or binding.A review of the adapter and handle device history records indicates the device lot numbers were released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be 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: 5468120
• MDR Text Key: 39310464
• Report Number: 1219930-2016-00173
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N5B0925LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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