MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GRASP; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number	174233
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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, after repeated articulation, the device got damaged with a rub-like scratch on the semi-transparent part of the articulation.This happened during laparoscopic total cystectomy.Another product was used to complete the case.There was no patient injury.

• Brand Name: ENDO GRASP
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 12675836
• Report Number: 2647580-2021-03557
• Device Sequence Number: 14592642
• Product Code: GET
• UDI-Device Identifier: 10884523000818
• UDI-Public: 10884523000818
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914753
• 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
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 174233
• Device Catalogue Number: 174233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1