MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8312, XS ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8312
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
Vats - "this device inserts the green ring to patient body.When they curling the white ring and find out the sheath is separated with green ring.Please consult with attached photo.Two of c8312 were used in two surgeries on same day.One of c8312 was abandoned by client." patient status - "fine.".
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon evaluation, engineering confirmed the complainant's experience of a sheath tear within the ring-to-ring zone, along the inner ring.They also noted a puncture mark along the film tear.Engineering's analysis has determined that it is likely the unit was punctured during the retraction.After the film was punctured, the tear propagated further.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: C8312, XS ALEXIS WND PROT/RET 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6457098
• Report Number: 2027111-2017-01647
• Device Sequence Number: 563043
• Product Code: KGW
• UDI-Device Identifier: 00607915117245
• UDI-Public: (01)00607915117245(17)190914(30)01(10)1278067
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K041711
• 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): 05/02/2017

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: 09/14/2019
• Device Model Number: C8312
• Device Catalogue Number: 100820801
• Device Lot Number: 1278067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1