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

Model Number	C0600
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure not provided - "disposable premium trocar system universal (12 mm disposable seal with stopcock) broke (black rubber piece came out of center) when surgeon attempted to put trocar through and pull it out." additional information received via email from distributor on january 18, 2017 - it was believed that the rubber seal detached when the obturator was first put through the cannula, as the surgeon attempted to use the apparatus and deemed it not functioning.The surgeon then removed the apparatus from the patient and when examining it for why it was not working, removed the obturator from the cannula, and it was obvious the rubber seal was detached/broken.The seal did not fall into the patient as far as the distributor knows.Patient status - "no adverse patient event/patient harm reported".
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.The likely root cause of the damage to the seal is 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.

• 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: 6309613
• Report Number: 2027111-2017-00840
• Device Sequence Number: 635071
• Product Code: GCJ
• UDI-Device Identifier: 00607915114831
• UDI-Public: (01)00607915114831(17)190823(30)01(10)1274887
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: Other
• Device Expiration Date: 08/23/2019
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1274887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 05/03/2017
• Patient Sequence Number: 1