MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8322, XS ALEXIS WND PROT/RET SHRT 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Engineering is investigating the returned unit.A follow up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: breast procedure.Limited information provided.Email that was sent by facility stated that alexis is arriving with holes in it.Discovered during surgery and completed the case with the event device.This did not delay or time.There are no photos available.Product will be returned.Additional information received via phone on 14aug2019 from applied medical account mgr.The holes were in the sheath of the alexis.They did not notice the holes until they removed the alexis at the end of the case.The surgeon has been using the alexis for 2 to 3 years with the mini richardson retractors and has not had an issue.Intervention: completed with same device as holes were not found until after the case was completed.Patient status: no patient injury.
Event or Problem Description
Procedure performed: breast procedure.Detailed description of event: limited information provided.Email that was sent by facility stated that alexis is arriving with holes in it.Discovered during surgery and completed the case with the event device.This did not delay or time.There are no photos available.Product will be returned.Additional information received via phone on 14aug2019 from applied medical account mgr.The holes were in the sheath of the alexis.They did not notice the holes until they removed the alexis at the end of the case.The surgeon has been using the alexis for 2 to 3 years with the mini richardson retractors and has not had an issue.Type of intervention: completed with same device as holes were not found until after the case was completed.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.The complainant's experience could not be confirmed as engineering did not observe any sheath tears or other non-conformances.Applied medical has reviewed the details surrounding the event and related product and is unable to confirm that a product malfunction occurred, as the event unit met current specifications.

• Brand Name: C8322, XS ALEXIS WND PROT/RET SHRT 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8927268
• Report Number: 2027111-2019-00569
• Device Sequence Number: 10835323
• Product Code: KGW
• UDI-Device Identifier: 00607915132958
• UDI-Public: (01)00607915132958(17)220523(30)01(10)1356320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 05/23/2022
• Device Model Number: C8322
• Device Catalogue Number: 101380701
• Device Lot Number: 1356320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MINI RICHARDSON RETRACTORS