MAUDE Adverse Event Report: APPLIED MEDICAL 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	12/18/2017
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 the investigation.
Event or Problem Description
Procedure performed: excision biopsy cervical node incident description: first time meeting [physician] who is an ent surgeon.Agreed to try an alexis for his excision biopsy of cervical node.In serviced on how to use before the procedure and showed him and his registrar a video of the alexis being used in a thyroidectomy.After making his incision and skin flap he tried to place the xs akexis but it was too large.I opened a sterile xxs which fit in the skin flap.When rolling the alexis down [physician] and [his registrar] held the outer ring either side and rolled downwards.The sheath became twisted as they rolled down so they were unable to get the circumfriental retraction.They tried to correct the twist but it didn't work so they removed the alexis by bulling the string through the middle.When the alexis was passed to the scrub nurse i noticed it had torn where the sheath was twisted over the outer ring.Mentioned to the surgeon about the rip and he was aware of the rip and thinks he may have caused it when rolling the sheath down.Patient status: did a patient injury or illness occur associated with the complaint event? no.Type of intervention: ni.
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 that the tear exhibited stress marks.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the user during deployment of the device.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; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7162466
• Report Number: 2027111-2018-00001
• Device Sequence Number: 64300
• Product Code: KGW
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129(17)190513(30)01(10)1270927
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: EXEMPT
• 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): 03/19/2018

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: Other
• Device Expiration Date: 05/13/2019
• Device Model Number: C8313
• Device Catalogue Number: 101355501
• Device Lot Number: 1270927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 03/19/2018
• Patient Sequence Number: 1