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

Model Number	030813
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
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 resection of appendix on a laparoscopic appendectomy, the stapler was able to fire however a blue plastic component broke off and fell into the patient¿s cavity.The component was retrieved with a grasper through the cannula.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of a photo and one device.The visual inspection of the instrument body displayed no abnormalities.The visual inspection of the cartridge noted the single use loading unit (sulu) was fully applied.Further inspection noted that the cartridge of the sulu was partially disengaged from the channel.The three knobs on the posterior side of the disengaged cartridge of the sulu were broken.Inspection under the microscope displayed nicks on the knife blade.Functionally, the knife blade and cam bars were reset.The approximating lever opened fully and the sulu unloaded and loaded repeatedly without difficulty.The instrument and sulu were applied to test media with acceptable results; the pushers advanced, the knife cut completely and cleanly, despite the noted knife blade damage.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed cartridge damage to the sulu may occur if the cartridge of the sulu is subjected to excessive force when attempting to unload the device.The release button at the distal end of the instrument should be utilized for proper removal of the sulu.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.Additionally, the investigation detected an unreported condition of damaged knife that has no relationship to the reported conditions.No further actions have been deemed necessary at this time.Replication of the observed unreported knife damage may occur if the instrument is applied over an obstruction.The instructions for use also states: when positioning the instrument on the application site ensure that no obstructions such as previously clips are incorporated into the instrument jaws.Firing over an obstruction may result in improperly formed staples.Improperly formed staples may result in leakage or disruption of the staple line.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: 9843487
• Report Number: 2647580-2020-00977
• Device Sequence Number: 743365
• Product Code: GDW
• UDI-Device Identifier: 10884523003796
• UDI-Public: 10884523003796
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/29/2020

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: 08/31/2024
• Device Model Number: 030813
• Device Catalogue Number: 030813
• Device Lot Number: P9J0180MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1