MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8301, S ALEXIS WND PROT/RET 5/BX; KGW

Model Number	C8301
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a torn sheath.Engineering observed cut marks on the sheath near the outer ring, a large tear, and separation of the film from the inner ring.Based on the condition of the returned unit, it is likely that the tear in the sheath was caused by the instrumentation used by the surgeon.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 updates to product literature and/or device enhancements, which are intended to further minimize the likelihood for this type of event to occur.
Event or Problem Description
Procedure performed: "herniotomy".Event description: "insert the green ring through the incision.When surgeon curling the white ring but the wound sheath was broken on the green ring.Please consult with photos." type of intervention: na.Patient status: "no patient injury".

• Brand Name: C8301, S 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: 7379897
• Report Number: 2027111-2018-00124
• Device Sequence Number: 1373125
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207(17)201108(30)01(10)1310445
• 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
• Report Date (Section B): 03/28/2018

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: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: C8301
• Device Catalogue Number: 101355701
• Device Lot Number: 1310445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/28/2018
• Patient Sequence Number: 1