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

Model Number	174233
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
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, during laparoscopic cholecystectomy, when the device was opened and the activation was checked, the jaws could not open.A new product was opened and the procedure was performed.The event occurred during the procedure but the product was not used for patient.
Additional Manufacturer Narrative
Additional info: if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing carried out by engineering found that there were no abnormalities that would cause or contribute to the reported condition.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.If information is provided in the future, a supplemental report will be issued.

• 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: 7847554
• Report Number: 2647580-2018-04419
• Device Sequence Number: 13968650
• Product Code: GET
• UDI-Device Identifier: 20884523000815
• UDI-Public: 20884523000815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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: 11/30/2021
• Device Model Number: 174233
• Device Catalogue Number: 174233
• Device Lot Number: P6L0090X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 01/09/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 01/08/2019; 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1