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

Model Number IDRVULTRA1

Device Problems Misfire (2532); Separation Failure (2547); Failure to Form Staple (2579)

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

Event Date 09/28/2017

Event Type  malfunction  

Event Description

According to the reporter: occurred during a laparoscopic thoracic segmentectomy procedure.The stapling device was being used for resecting the tumor off of the lung.The stapler was able to fire, but the stapler did not fire all the way to the distal end.Stopped approximately four to five millimeters from the distal tip.And did not release the suture on the reinforced reloads, the material was torn loose from the reload.The staple line was incomplete at the distal end.In order to resolve the issue and complete the case, the sutures was cut with shears.There was no patient harm.The patient outcome is alive, no injury.

Manufacturer Narrative

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

• Brand Name: IDRIVE ULTRA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6961137
• MDR Text Key: 90106255
• Report Number: 1219930-2017-08074
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 12/08/2017
• 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 Age: 64 YR