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

Model Number	030807L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the laparoscopic appendectomy procedure, the stapler only released staples on one side so intestine was open and they needed to staple one more time.In order to complete the case, they took a new reload and stapled one more time.It was noted there was unanticipated tissue loss more than an ordinary surgery and tissue damage as a result of the problem.There was no blood loss of 500cc or more and the surgical time was not extended by 30 min or more.There were no temporary or permanent complications.The patient was fine post-op.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device opened by the account with the appropriate packaging in undamaged condition.The visual inspection of the returned product noted that the visual inspection of the cartridge noted that only one side of the staples was deployed.Inspection under the microscope displayed no damage to the knife blade.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of the device.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the observed 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: 6618457
• Report Number: 2647580-2017-05539
• Device Sequence Number: 712751
• Product Code: GDW
• UDI-Device Identifier: 10884523003772
• UDI-Public: 10884523003772
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 030807L
• Device Catalogue Number: 030807L
• Device Lot Number: P4L0554X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017; 05/05/2017; 05/05/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/13/2017; 10/05/2017
• 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: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 55