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

Model Number	C8312
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic myomectomy.Event description: complaint 1 of 2: (b)(4), complaint 2 of 2: (b)(4).During the surgery, a gas leakage issue was noticed after a period of operation.When the user removed the c8312 for inspection, it was found that the green ring had partially detached from the wound sheath.After replacing it with a new one, the same issue occurred again after some time.User replace with a new one to complete this surgery.Additional information provided by [name] on 20 jan 2025 via email: the malfunction occurred mid-procedure.It was observed that the patient's abdominal insufflation had decreased, leading to the suspicion of a potential air leakage.Upon investigation, it was identified that the leakage originated from c8312.The issue was confirmed when c8312 was removed from the patient, revealing the problem.The sheath became detached at the connection point within the green ring.No instruments were used within the alexis during placement.No instruments were used within the alexis during the procedure.The device did not particulate.Intervention: user replace with a new one to complete this surgery.Patient status: the patient is in good condition.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic myomectomy.Event description: during the surgery, a gas leakage issue was noticed after a period of operation.When the user removed the c8312 for inspection, it was found that the green ring had partially detached from the wound sheath.After replacing it with a new one, the same issue occurred again after some time.User replace with a new one to complete this surgery.Additional information provided by [name] on 20jan2025 via email: the malfunction occurred mid-procedure.It was observed that the patient's abdominal insufflation had decreased, leading to the suspicion of a potential air leakage.Upon investigation, it was identified that the leakage originated from c8312.The issue was confirmed when c8312 was removed from the patient, revealing the problem.The sheath became detached at the connection point within the green ring.No instruments were used within the alexis during placement.No instruments were used within the alexis during the procedure.The device did not particulate.Intervention: user replace with a new one to complete this surgery.Patient status: the patient is in good condition.
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 and the description of the event, it is likely that a sharp object or instrument came into contact with the sheath, resulting in a hole or tear that further propagated during use.It is possible that the fully unflipped inner ring made the sheath more susceptible to separating from the inner ring.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.

• Brand Name: ALEXIS 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: 21377168
• Report Number: 2027111-2025-00360
• Device Sequence Number: 8459407
• Product Code: KGW
• UDI-Device Identifier: 00607915117245
• UDI-Public: (01)00607915117245
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: C8312
• Device Catalogue Number: 100820801
• Device Lot Number: 1529550
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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