MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS O WOUND PROTECTOR-RETRACTOR; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8401
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
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: vats.Description of event: complaint 1 of 2: (b)(4) model c8401 lot 1506767 (b)(6) ea.Complaint 2 of 2: (b)(4) model c8401 lot 1506767 (b)(6) ea.Two device malfunctions occurred during the same procedure.[hospital] i¿m here at the [facility] in another vats case.2 more alexis tore at the ring.Same lot number as the previous one: lot # 1506767.Additional information received from account manager via email on 28aug2024: they are going to save the 2 from today to send back to corporate the product is available for return.Additional information received from account manager via email on 29aug2024: no patient injury occurred.The surgeon opened a new alexis to complete the procedure.The first alexis sheath tore mid-procedure.The second alexis tore mid-procedure.Suction, bovie, and stapler were used within the alexis.The sheath did not particulate.Additional information received from account manager via email on 29aug2024: they will return the 2 alexis that were used in the case yesterday.Intervention: the surgeon opened a new alexis to complete the procedure.Patient status: no patient injury.
Event or Problem Description
Procedure performed: vats description of event: complaint 1 of 2: (b)(4) model c8401 lot 1506767 1ea - mfr# 2027111-2024-00833.Complaint 2 of 2: (b)(4) model c8401 lot 1506767 1ea - mfr# 2027111-2024-00834.Two device malfunctions occurred during the same procedure.[hospital]: i¿m here at the [facility] in another vats case.2 more alexis tore at the ring.Same lot number as the previous one: lot # 1506767.Additional information received from account manager via email on 28aug2024: they are going to save the 2 from today to send back to corporate the product is available for return.Additional information received from account manager via email on 29aug2024: no patient injury occurred.The surgeon opened a new alexis to complete the procedure.The first alexis sheath tore mid-procedure.The second alexis tore mid-procedure.Suction, bovie, and stapler were used within the alexis.The sheath did not particulate.Additional information received from account manager via email on 29aug2024: they will return the 2 alexis that were used in the case yesterday.Intervention: the surgeon opened a new alexis to complete the procedure.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the inner ring separating from the sheath.Based on the condition of the returned unit and the description of the event, it is likely that the sheath was not properly heat sealed to the ring, causing a weak or incomplete film-to-ring seal.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.[correction] the brand name in section d1 and the primary udi number in section d4 have been updated.

• Brand Name: ALEXIS O WOUND PROTECTOR-RETRACTOR
• 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: 20262804
• Report Number: 2027111-2024-00834
• Device Sequence Number: 20907549
• Product Code: KGW
• UDI-Device Identifier: 00607915117252
• UDI-Public: (01)00607915117252
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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 Model Number: C8401
• Device Catalogue Number: 100938801
• Device Lot Number: 1506767
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SUCTION, BOVIE, AND STAPLER
• Patient Sex: Unknown