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

Model Number 174233

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2017

Event Type  malfunction  

Event Description

According to the reporter, during use on the patient, the jaws would not open properly.When the device was articulated, the jaws could not open.The procedure was completed with another device.There was no injury caused to the patient and no medical intervention was required as a result of the device issue.

Manufacturer Narrative

Post market vigilance (pmv) received one device.The visual inspection of the returned product noted no abnormalities.Pmv performed functional testing which included the following: the rotation knob functioned without difficulty.The jaws extended and retracted without difficulty.The jaws were opened, closed, and applied to test media and grasped the media without issue.Additional information : if information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GRASP
• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6945849
• MDR Text Key: 89851574
• Report Number: 2647580-2017-07158
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 20884523000815
• UDI-Public: 20884523000815
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K914753
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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
• Device Operator: 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: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 12/05/2017
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1