MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE BATTERY PACK; STAPLE, IMPLANTABLE

Model Number INTB100

Device Problems Unintended Arm Motion (1033); Calibration Problem (2890)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history records has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications.A review of historical complaint data displayed no increase in trends.

Event Description

According to the reporter, during the sleeve gastrectomy, the device calibrated inside the abdomen, and the reload moved on its own.There was no injury or adverse event reported.A manual handle was used to complete the procedure.No reinforcement material was used.There was no blood loss over 500 cc's.

• Brand Name: IDRIVE BATTERY PACK
• 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: 5704403
• MDR Text Key: 46738749
• Report Number: 1219930-2016-00596
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K102325
• 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: 03/01/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: INTB100
• Device Catalogue Number: INTB100
• Device Lot Number: C3M7201UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Treatment: PRODUCT NUMBER: IDRVULTRA1