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

Model Number	173051
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	11/06/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO LUNG
• 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: 7085819
• Report Number: 2647580-2017-08368
• Device Sequence Number: 16458780
• Product Code: GET
• UDI-Device Identifier: 20884523000785
• UDI-Public: 20884523000785
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K904578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/23/2018; 02/21/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/02/2018; 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1