MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8405, XXL ALEXIS O WND PRO/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8405
Medical Device Problem Codes	Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: (b)(6).Event description: breakage of the plastic part of the alexis retractor, clinical consequences observed: risk of residual fragments.Additional information received from applied medical representative via email 6sep22: sheath breaking.Risk of small parts (fragments) of the sheath additional information received from applied medical representative via email 9sep22: the incident took place at the emergencies or.No more details at the moment.Additional information received from applied medical representative via email 20sep22: the incident took place at the emergencies or by night and i did not find anybody who could explain to me what occurred.Patient status: no patient injury has been reported.Type of intervention: (b)(6).
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of sheath tear.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument or object that came in contact with the sheath, resulting in a hole or tear.As the sheath experiences stresses during use, it is possible that the hole or tear propagated through the sheath.
Event or Problem Description
Procedure performed: ni.Event description: breakage of the plastic part of the alexis retractor.Clinical consequences observed: risk of residual fragments.Additional information received from applied medical representative via email 6sep22: sheath breaking.Risk of small parts (fragments) of the sheath.Additional information received from applied medical representative via email 9sep22: the incident took place at the emergencies operating room.No more details at the moment.Additional information received from applied medical representative via email 20sep22: the incident took place at the emergencies or by night and i did not find anybody who could explain to me what occurred.Patient status: no patient injury has been reported.Type of intervention: ni.

• Brand Name: C8405, XXL ALEXIS O WND PRO/RET 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15530178
• Report Number: 2027111-2022-00756
• Device Sequence Number: 17661896
• Product Code: KGW
• UDI-Device Identifier: 00607915127190
• UDI-Public: (01)00607915127190(17)240603(30)01(10)1418029
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 06/03/2024
• Device Model Number: C8405
• Device Catalogue Number: 101356501
• Device Lot Number: 1418029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown