MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8313, XXS ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8313
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.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
Vats.Lobectomy - in [surgeon's] second case he inserted 2 xxs alexis at start of the case.At the point of removing the specimen (around one hour into case) a small tear near the green ring of the alexis was noticed and was subsequently replaced.At the end of the case on removing the 2nd xxs alexis another small tear again near to the green deployment ring was evident.During the case a number of instruments were placed through the alexis including covidien stapler, diathermy, forceps and scissors.Additional information received via email from applied medical team member, february 8, 2017: all surgeons have been using alexis regularly (xs & xxs) since last quarter.Additional instruments used (not a definitive list but most commonly): diathermy (hook), stapler (covidien/ethicon), hem-o-lok and various instruments from there set including forceps, scissors, grasper & clamps).[surgeon] commented that it may have been possible that he had caught the sheath with his hook diathermy.Patient status - no patient injury or illness associated with the event.Additional information received via email from applied medical team member, february 8, 2017: "all fine.No patient illness or injury occurred in any of the cases.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon evaluation, engineering confirmed the complainant's experience of a torn sheath and noted a tear approximately ½ inch from the inner ring.The tear was oval shaped and had jagged edges all the way around.Engineering's analysis has determined that it is likely the initial tear in the sheath was caused by the instrumentation used by the surgeon.The propagation of the tear was likely caused by the doctor placing additional stress on the initial puncture when removing the alexis unit.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: C8313, XXS 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: 6363311
• Report Number: 2027111-2017-01511
• Device Sequence Number: 968242
• Product Code: KGW
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129(17)190708(30)01(10)1274511
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K041711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: 07/08/2019
• Device Model Number: C8313
• Device Catalogue Number: 101355501
• Device Lot Number: 1274511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/22/2017
• Patient Sequence Number: 1