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

Model Number 174233

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic colectomy, when the surgeon reticulated the device, he/she noticed that "plastic was off inside of the product." the product was replaced to complete the case.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 6994281
• MDR Text Key: 91297803
• Report Number: 2647580-2017-07528
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 20884523000815
• UDI-Public: 20884523000815
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• 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: P6L0089X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• 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