MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR03
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.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.
Event or Problem Description
No procedure performed - "the nurse noticed a hole in the pouch packaging of the trocar." type of intervention: na.Patient status: na.
Additional Manufacturer Narrative
Investigation summary: the event product was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience of a hole in the pouch.A tear was also observed on the pouch.The root cause of the event is likely due to improper handling of the product during or after distribution.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.
Event or Problem Description
Additional information received via telephone from customer on (b)(6) 2017: they received product in a box.It was not part of a custom kit.The product was stored in omnicell which is a type of supply management system and inventory storage unit.It was described as a shelving unit that houses each product individually.The rn was not 100% certain, but the hole was most likely noticed in the operating room prior to surgery.It was not known if other devices were nearby.

• Brand Name: CFR03, 5X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6220376
• Report Number: 2027111-2016-00914
• Device Sequence Number: 13540672
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)190420(30)01(10)1268503
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 04/20/2019
• Device Model Number: CFR03
• Device Catalogue Number: 101221201
• Device Lot Number: 1268503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1