MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIAADAPT

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Activation (2577); Human-Device Interface Problem (2949); Torn Material (3024)

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

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: there was a problem loading and unloading the adapter onto the handle.When trying to assemble the powered handle, the unload button was very stiff.The unload button is broken and broke off from the device.The device sterilization method is autoclave and the type of cleaning is manual.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of the device.Visual and functional evaluation noted that the lock out slider block was damaged and the non-welded tip housing was damaged.The load ring was found overlapping the leaf spring.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Damage to the lockout slider block is consistent with a user attempting to fire a sulu when one is not fully attached.When the block becomes jammed it can prevent the lockout cam block and sulu load link from returning to its resting state.The sulu load link connects to the "unload" button, in turn causing that to become stuck in place.Damage to unload button can be replicated through rough handling.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• 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: 6566228
• MDR Text Key: 75098218
• Report Number: 1219930-2017-05558
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2017
• Date Device Manufactured: 11/01/2016
• 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