MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.Visual inspection noted the e-piece of the instrument had disengaged.The single use loading unit (sulu) was loaded onto a test instrument from for functional testing.The test instrument and sulu were applied to the appropriate test media.The remaining seven staples deployed and seated properly in the test media.It was reported that the loading unit disengaged from the handle and a component disengaged from the device.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur as a result of excessive manipulation of the device during use or due to improper loading and/or unloading of the sulu.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: when unloading: first, hold the instrument body firmly in the palm of your hand.Position the instrument so that the yellow alert indicator window is on top.Place fingers on the three colored dots, two placed on the side and one placed on the top front of the sulu.Place firmly until the sulu snaps away from the instrument.The instrument is now ready for reloading.When loading: first, remove the sulu from the blister package.Insert the sulu in the opposite direction as removed.Place the tip of the sulu under the forward lip.Press the sulu firmly into the instrument until there is an audible click.The instrument is now ready for use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic hernia repair, the loading unit fell off into patient's cavity when the device was inserted.The reload had been retrieved.There was no patient injury.

• Brand Name: MULTIFIRE ENDO HERNIA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 11941100
• Report Number: 2647580-2021-01917
• Device Sequence Number: 17232558
• Product Code: GCJ
• UDI-Device Identifier: 10884521070547
• UDI-Public: 10884521070547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K912097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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 Model Number: 174007
• Device Catalogue Number: 174007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1