MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0600, UNIVERSAL SEAL, (PETALS) 20/BX; GCJ

Model Number	C0600
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical.Visual inspection confirmed the complainant's experience of leakage due to fragmentation of an internal rubber component of the seal.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an instrument.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report represents the combined initial and final.Based on the description of the event, the event was deemed not reportable as it was unlikely to cause or contribute to death or serious injury.After evaluation by engineering, the event is deemed reportable due to fragmentation of an internal component of the seal.
Event or Problem Description
Procedure performed: stomach operation; additional information received via email from sales representative on 03aug2017: gastrectomy.Event description: after use10mm instrument (scope) and stapler, the seal is leaky when the chirurge use 5mm instruments (grasper, scissor or dissector).The loss of pneumo was gradual.The surgeon using the scope not differently than usual.The hospital has experienced similar issues last year.Ame following up with tm to see if additional cers need to be created.Additional information received via email from sales representative on 03aug2017: there were 6 seals used during this procedure.Leakage occurred with each seal.Additional cers created (6 total: 2017-1496 + 2017-1514 + 2017-1515 + 2017-1516 + 2017-1517 + 2017-1518) type of intervention: n/a.Patient status: did a patient injury or illness occur associated with the complaint event? no.

• Brand Name: C0600, UNIVERSAL SEAL, (PETALS) 20/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6927395
• Report Number: 2027111-2017-02043
• Device Sequence Number: 11091006
• Product Code: GCJ
• UDI-Device Identifier: 00607915114831
• UDI-Public: (01)00607915114831(17)200305(30)01(10)1291111
• Combination Product (Y/N): N
• PMA/510(K) Number: K932995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2020
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1291111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1