MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GTK14, ALEXIS CES 14CM W KII BALLOON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	GTK14
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a follow-up to medwatch # (b)(4).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.Na (before use).Detailed description of event: "issue: surgeon asked for a sterile disposable supply.Orientee rn opened product.Product was not factory sealed on one edge.Surg tech accepted product without knowledge of unsealed.She changed gloves when issue discovered, product not put on sterile field." product is available for return.Type of intervention: na (before use).Patient status: na (before use).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of an open seal on one edge.Based on the condition of the returned unit, it is possible that the pouch was not sealed during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Name of procedure being performed.Na (before use).Detailed description of event."issue: surgeon asked for a sterile disposable supply.Orientee rn opened product.Product was not factory sealed on one edge.Surg tech accepted product without knowledge of unsealed.She changed gloves when issue discovered, product not put on sterile field." product is available for return.Type of intervention.Na (before use).Patient status.Na (before use).

• Brand Name: GTK14, ALEXIS CES 14CM W KII BALLOON
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16540124
• Report Number: 2027111-2023-00375
• Device Sequence Number: 17944951
• Product Code: GCJ
• UDI-Device Identifier: 20607915137070
• UDI-Public: (01)20607915137070(17)250919(30)01(10)1478289
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 09/19/2025
• Device Model Number: GTK14
• Device Catalogue Number: 700315185
• Device Lot Number: 1478289
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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
• Patient Sex: Unknown