MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8502, M ALEXIS LAP SYS 6/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8502
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: right hemicolectomy.Description of event: [name] medical center."the packaging was found to be opened before use." product is available for return.Additional information was received via phone on 27mar2024 from [name] amk territory manager "there was miscommunication between the hospital and the dealer.The event is not about the open package.The event is that the sheath was found torn." type of intervention: the case was completed with the new device.Patient status: na (not used on patient).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a tear in the packaging.Based on the condition of the returned unit, it is possible that the tear in the packaging was caused by a sharp object.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: right hemicolectomy.Description of event: [name] medical center."the packaging was found to be opened before use." product is available for return.Additional information was received via phone on 27mar2024 from [name] amk territory manager "there was miscommunication between the hospital and the dealer.The event is not about the open package.The event is that the sheath was found torn." additional information was received via email on 18jun2024 from cp engineering: "during the initial visual inspection of the event unit returned for complaint (b)(4), a tear was observed on the tyvek side of the flat pouch.Initially, the complaint was reported as a packaging issue, but additional information later suggested that the non-conformance was due to a sheath tear.However, during inspection, it was evident that the alexis device could not have been pulled out of the pouch through the small tear, thus negating the claim of a torn sheath.A secondary visual inspection was performed, during which the pouch was opened to further investigate the condition of the sheath.This inspection confirmed that the sheath was intact and conforming to the expected standards.Please refer to some pictures of the damage on the pouch and the conforming sheath." type of intervention: the case was completed with the new device.Patient status: na (not used on patient).

• Brand Name: C8502, M ALEXIS LAP SYS 6/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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 19006986
• Report Number: 2027111-2024-00478
• Device Sequence Number: 20948419
• Product Code: KGW
• UDI-Device Identifier: 00607915119935
• UDI-Public: (01)00607915119935(17)260226(30)01(10)1481951
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 02/26/2026
• Device Model Number: C8502
• Device Catalogue Number: 101357101
• Device Lot Number: 1481951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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