MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8323
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
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: vat left upper lobectomy.Event description: [facility] hospital.This is a complaint from the market.Report from the sales rep; forceps, suction tubes, sutures, and electrocautery were inserted and removed postoperatively, and the sheath was torn.It is unknown if any debris remains in the body cavity.Surgery time is 3 hours, as usual.The damage was confirmed after the surgery was completed.The event unit will be returned to amr for further evaluation.Intervention: ni.Patient status: unknown // the part of seath can be remained in the patient body.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of sheath tear.It was also observed that a part of the sheath was stretched and edges near the tear were rough.Based on the condition of the returned unit, it is likely that an object or instrument 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 when the device was being retracted.
Event or Problem Description
Procedure performed vat left upper lobectomy event description: [facility] hospital this is a complaint from the market.Report from the sales rep; forceps, suction tubes, sutures, and electrocautery were inserted and removed postoperatively, and the sheath was torn.It is unknown if any debris remains in the body cavity.Surgery time is 3 hours, as usual.The damage was confirmed after the surgery was completed.The event unit will be returend to amr for further evaluation.Intervention: ni patient status: unknown // the part of seath can be remained in the patient body.

• Brand Name: C8323, XXS ALEXIS WND PROT/RET SHRT 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17114143
• Report Number: 2027111-2023-00491
• Device Sequence Number: 20691644
• Product Code: KGW
• UDI-Device Identifier: 00607915132941
• UDI-Public: (01)00607915132941(17)250731(30)01(10)1462134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: 07/31/2025
• Device Model Number: C8323
• Device Catalogue Number: 101432601
• Device Lot Number: 1462134
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: FORCEPS, SUCTION TUBES; SUTURES, AND ELECTROCAUTERY
• Patient Sex: Unknown