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

Model Number	173022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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 a procedure, the device was found broken after opening the package.The device was replaced with a new one to complete the case.There was no patient injury.

• Brand Name: ENDO CLOSE
• 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: 9711271
• Report Number: 2647580-2020-00595
• Device Sequence Number: 11391376
• Product Code: GCJ
• UDI-Device Identifier: 10884521051492
• UDI-Public: 10884521051492
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 08/31/2023
• Device Model Number: 173022
• Device Catalogue Number: 173022
• Device Lot Number: P8H1812X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1