MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030811
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy procedure, the device did not click when fired.The device was not able to fire.They had to open another device to finish the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the cartridge of the single use loading unit (sulu) noted the sulu was partially applied with the interlock engaged.This prevented the instrument from firing.A review of the device history record indicates the product was released meeting all quality release specifications.Replication of the observed condition may occur if the handle is not completely compressed during application.This partial firing causes the interlock to engage and if a second attempt is made to fire the sulu it will not fire.The instructions for use for this product states: failure to firmly squeeze the handle all the way may result in an incomplete staple formation, which may compromise the integrity of the staple line.The device is equipped with a safety interlock which prevents the handle from being squeezed a second time.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8432144
• Report Number: 2647580-2019-01444
• Device Sequence Number: 16556800
• Product Code: GDW
• UDI-Device Identifier: 10884523003789
• UDI-Public: 10884523003789
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 08/31/2023
• Device Model Number: 030811
• Device Catalogue Number: 030811
• Device Lot Number: P8H1824MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1