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

Model Number	030805L
Medical Device Problem Codes	Entrapment of Device (1212); Misfire (2532); Failure to Form Staple (2579); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during an open pelvic exenteration, when the stapler was being applied to the internal iliac vessel, the scrub nurse struggled to reload the stapler initially.The supporting surgeon helped in loading the reload onto the handle.When the surgeon tried to fire the stapler the device made a large cracking noise and got stuck to the vessel.There were poor staple formation and the distal staple line was incomplete.The surgeon struggled to remove the device and decided to clamp the vessel and tie it off.Once the stapler was removed the staples were partially fired.The handle and first reload had been fired successfully, however this was the second reload on the device.The surgeon had to clamp the internal iliac vein and then sew the vessel before removing the stapler in order to ensure haemostasis was achieved and the vessel did not rupture.The surgical time was extended by more t han 30 minutes.
Additional Manufacturer Narrative
Investigation summary: post market vigilance (pmv) led an evaluation of one device.Nicks were observed on the knife blade and the knife blade was received severely bent.Further inspection noted that the cartridge of the single use loading unit (sulu) was disengaged from the channel.In addition, three knobs on the posterior side of the disengaged cartridge of the sulu were broken.A review of the device history record indicates the product was released meeting all quality release specifications.Replication of the observed 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.The root cause of the observed knife damage was misuse of the product which caused or contributed to the reported condition.Additionally, the investigation detected a secondary condition of disengaged cartridge that has no relationship 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: 7842489
• Report Number: 2647580-2018-04378
• Device Sequence Number: 1431297
• Product Code: GDW
• UDI-Device Identifier: 20884523003762
• UDI-Public: 20884523003762
• 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): 11/28/2018

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: 04/30/2022
• Device Model Number: 030805L
• Device Catalogue Number: 030805L
• Device Lot Number: P7D1255MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: Required Intervention