MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE VERSATACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174021
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted no visual abnormalities.During firing, the tacks seated properly, but handle did not retract after firing.The leaf spring was loose on handle.The unit was opened as instructed by engineering and it was noted the leaf spring was detached and rolled.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.Root cause of the reported condition is due to an excessive amount of adhesive being applied to the spring retainer during the assembly process.A process improvement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was in small pieces.There was no patient involvement.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE VERSATACK
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7734753
• Report Number: 2647580-2018-03826
• Device Sequence Number: 1398907
• Product Code: GCJ
• UDI-Device Identifier: 20884521070568
• UDI-Public: 20884521070568
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 174021
• Device Catalogue Number: 174021
• Device Lot Number: P7C0904X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization