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

Model Number	C8301
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Medwatch form #0505160000-2018-8004 received via mail on (b)(6) 2018.Date of the event was (b)(6) 2018.F as specimen was being removed through device, the bag/device partially ripped.Patient status: unknown.Type of intervention: unknown.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.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.This report is to follow up medwatch report #0505160000-2018-8004.
Event or Problem Description
Medwatch form # (b)(4) received via mail on 30jul2018.Date of the event was (b)(6) 2018.F as specimen was being removed through device, the bag/device partially ripped.Additional info received on august 7, 2018: did a patient injury or illness occur associated with the complaint event? no.Patient status (what happened as a result of this event?): surgery completed and patient stable.Can you identify the location of the rip? did the sheath particulate? unsure.Was all material retrieved? yes.Was the device removed and replaced? yes.How was the case completed? device sent to manufacture.

• Brand Name: C8301, S ALEXIS WND PROT/RET 5/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7825025
• Report Number: 2027111-2018-00326
• Device Sequence Number: 19216279
• Product Code: GCJ
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207(17)201018(30)01(10)1308542
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 10/18/2020
• Device Model Number: C8301
• Device Catalogue Number: 101355701
• Device Lot Number: 1308542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1