MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN IDRIVE HANDLE; STAPLE, IMPLANTABLE

Model Number UNKNOWN IDRIVE HANDLE

Device Problems Failure to Calibrate (2440); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic bariatric surgery at the second charge, the load did not close completely and the stapler did not finalize the calibration.The doctor still came in and tried to make the shot but the charge did not shut in the middle of the surgery.The load broke off and did not fall into the patient cavity.They substituted the device to complete the case.There was no patient injury.

• Brand Name: UNKNOWN IDRIVE HANDLE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8935213
• MDR Text Key: 155664701
• Report Number: 1219930-2019-04909
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN IDRIVE HANDLE
• Device Catalogue Number: UNKNOWN IDRIVE HANDLE
• Device Lot Number: 10884523002973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1