MAUDE Adverse Event Report: AMR C0600, UNIVERSAL SEAL, (PETALS) 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 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 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." type of intervention: "n/a." patient status: "no adverse/patient harm reported.".
Additional Manufacturer Narrative
Distributor cannot accept contaminated product from customer.The incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.During the manufacturing process, all seals are thoroughly inspected for functionality and performance prior to packaging.Although the root cause of the experience could not be determined, applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.

• Brand Name: C0600, UNIVERSAL SEAL, (PETALS) 20/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5823464
• Report Number: 2027111-2016-00539
• Device Sequence Number: 640152
• Product Code: GCJ
• UDI-Device Identifier: 00607915114831
• UDI-Public: (01)00607915114831(17)180901(30)01(10)1252035
• 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): 06/27/2016

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: 09/01/2018
• Device Model Number: C0600
• Device Catalogue Number: 100817701
• Device Lot Number: 1252035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 10/21/2016
• Patient Sequence Number: 1