MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS22
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: bariatric surgery.Detailed description of event: [facility] arsenalera noticed the presence of a hair the moment the trocar was presented to him while he was assembling his surgical table.Open input, with hair inside.Product is available for return.Additional information was received via email on 24oct2023 from [name] [distributor]: no, the device did not come into contact with the patient.The case was completed with another device cts22.Photos have been provided.Patient status: na (before use).Type of intervention: na (before use).
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: bariatric surgery.Detailed description of event: [facility]: [name].Noticed the presence of a hair the moment the trocar was presented to him while he was assembling his surgical table.Open input, with hair inside.Product is available for return.Additional information was received via email on 24oct2023 from [name] [distributor]: no, the device did not come into contact with the patient.The case was completed with another device cts22.Photos have been provided.Patient status: na (before use).Type of intervention: na (before use).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.

• Brand Name: CTS22, 12X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 18111575
• Report Number: 2027111-2023-00714
• Device Sequence Number: 20799232
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)260417(30)01(10)1488456
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K060096
• 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): 02/01/2024

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: 04/17/2026
• Device Model Number: CTS22
• Device Catalogue Number: 101244801
• Device Lot Number: 1488456
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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