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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: "report from the sales rep the foreign material was found when the balloon was injected the air.The case was completed with the new one.Initial investigation report the event unit was returned to us and visually inspected.We confirmed the brawn foreign material like a tissue on the proximal side of the balloon (pic.1).The unit will be returned to amr for further evaluation." intervention: the case was completed with the new one.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of a foreign material on the surface of the balloon.Based on the condition of the returned unit and the description of the event, it is likely that the material found on the balloon of the event unit was residual balloon material that adhered to the balloon during the balloon forming process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: ni.Event description: "report from the sales rep: the foreign material was found when the balloon was injected the air.The case was completed with the new one.Initial investigation report: the event unit was returned to us and visually inspected.We confirmed the brawn foreign material like a tissue on the proximal side of the balloon (pic.1).The unit will be returned to amr for further evaluation." intervention: the case was completed with the new one.Patient status: no patient injury.

• 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
• MDR Report Key: 11226821
• Report Number: 2027111-2021-00313
• Device Sequence Number: 11624649
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)230506(30)01(10)1388083
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 05/06/2023
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1388083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1