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	04/14/2021
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 mesh fixation in a hernia repair, 3 reloads have fell into the cavity when tried to be fired.They have been retrieved with an instrument.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: 11790809
• Report Number: 2647580-2021-01592
• Device Sequence Number: 3972017
• Product Code: GCJ
• UDI-Device Identifier: 10884521070547
• UDI-Public: 10884521070547
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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 Expiration Date: 03/31/2025
• Device Model Number: 174007
• Device Catalogue Number: 174007
• Device Lot Number: P0D1569Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR