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

Model Number	010911L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
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, prior a laparoscopic living donor nephrectomy, they tried to squeeze the handle to fire but the handle could not be squeezed.The cartridge was replaced and tried to be used again, but the device still could not fire.The procedure was completed with another device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The cartridge of the single use loading unit (sulu) was partially disengaged from the channel.In addition, a knob on the posterior side of the disengaged cartridge of the sulu was broken.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have 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.No further actions have been deemed necessary at this time.Replication of the observed secondary 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.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior a laparoscopic living donor nephrectomy, they tried to squeeze the handle to fire but the handle could not be squeezed.The cartridge was replaced and tried to be used again, but the device still could not fire.The procedure was completed with another device.The procedure was extended by less than 30 minutes.There was no patient injury.

• Brand Name: MULTIFIRE ENDO TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8171639
• Report Number: 2647580-2018-06135
• Device Sequence Number: 1459480
• Product Code: GDW
• UDI-Device Identifier: 10884521047761
• UDI-Public: 10884521047761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 03/31/2023
• Device Model Number: 010911L
• Device Catalogue Number: 010911L
• Device Lot Number: P8C1385MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1