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

Model Number	C0600
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2016
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 this report was submitted, then a 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 performed: unknown - "instrument catching inside of seal.No adverse event/patient harm reported." type of intervention - unknown.Patient status: no adverse event / patient harm reported.
Additional Manufacturer Narrative
Correction: event description and incident date.
Event or Problem Description
Procedure performed: unknown -"instrument catching inside of seal.No adverse event/patient harm reported.Event sample available but is contaminated.Please advise if the sample can be shipped direct from customer ((b)(6)) to applied medical.(b)(4) cannot accept contaminated product.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Engineering did not observe any damage to the components of the seal.Engineering attempted to replicate the customer's experience, but the customer's experience could not be replicated.The unit met acceptance criteria.During the manufacturing process, all seals are thoroughly inspected and tested for functionality prior to packaging.The root cause of the event is likely due to non-axial insertion of instruments.Although the exact root cause could not be confirmed, 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.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: C0600, UNIVERSAL SEAL 20/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6097744
• Report Number: 2027111-2016-00790
• Device Sequence Number: 1359536
• Product Code: GCJ
• UDI-Device Identifier: 00607915114831
• UDI-Public: (01)00607915114831(17)190228(30)01(10)1265176
• 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,Followup
• Report Date (Section B): 12/22/2016

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: 02/28/2019
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1265176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 11/14/2016; 12/22/2016
• Patient Sequence Number: 1