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

Model Number 173051

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

According to the reporter an issue occurred during preparation for a wedge / segmental resection procedure.The jaws of the device were checked and it was noted that they would not open or close.The device was not used on the patient.The procedure was completed with another device.

Manufacturer Narrative

Additional information: 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 LUNG
• 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: 7085819
• MDR Text Key: 93836516
• Report Number: 2647580-2017-08368
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 20884523000785
• UDI-Public: 20884523000785
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2018

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: 08/31/2021
• Device Model Number: 173051
• Device Catalogue Number: 173051
• Device Lot Number: P6H0381X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/23/2018; 02/21/2018
• Supplement Dates FDA Received: 02/02/2018; 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2016
• 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