MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8322, XS ALEXIS WND PROT/RET SHRT 5/BX; KGW

Model Number	C8322
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: appendectomy.Event description: "when a doctor rolled the outer ring up once, the sheath was torn.The surgeons replaced the product to new one and started over the procedure." additional information received via email from the distributor, on (b)(6) 2017.The doctor rolled the outer ring up outward once (=inside out?)." additional information received via email from the distributor, on (b)(6) 2017: the name of the procedure performed is appendectomy.I confirmed that other instruments didn't come in contact with the sheath.Type of intervention: replaced the product and "started over the procedure" patient status: no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath had partially separated from the white ring.Based on the condition of the returned unit, it is likely that the reported event was caused during the manufacturing process; however the exact root cause could not be confirmed.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: C8322, XS ALEXIS WND PROT/RET SHRT 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6850512
• Report Number: 2027111-2017-01972
• Device Sequence Number: 699064
• Product Code: KGW
• UDI-Device Identifier: 00607915132958
• UDI-Public: (01)00607915132958(17)200111(30)01(10)1287353
• Combination Product (Y/N): N
• 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): 10/23/2017

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: 01/11/2020
• Device Model Number: C8322
• Device Catalogue Number: 101432501
• Device Lot Number: 1287353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1