MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R50
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	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed na (incoming inspection).Event description: [distributor] incoming inspection po#24002.This is a complaint from [distributor] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: may 19, 2023.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.We found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.Hairlike object in pouch.Intervention: na (incoming inspection).Patient status: na (no patient involvement).
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
Procedure performed.Na (incoming inspection).Event description: [distributor] incoming inspection (b)(4).This is a complaint from [distributor] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: may 19,2023.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.We found the defects that already informed applied medical by cer.We just inform you the defect and return the products for following defects.You do not need investigation.Hairlike object in pouch - c0r50 lot #1477627 (1 ea.) type of intervention: na (incoming inspection).Patient status: na (no patient involvement).
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: C0R50, 12X130 KII BALLOON BLNT TIP 6/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: 17241169
• Report Number: 2027111-2023-00507
• Device Sequence Number: 6831552
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)260212(30)01(10)1477627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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: Other
• Device Expiration Date: 02/12/2026
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1477627
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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