MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF73
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.This report is to follow up medwatch # mw5105036.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: complaint created based on medwatch received by mail on 03-jan-2022.Report number mw5105036.The balloon broke while surgeon was manipulating the trocar in the patient's abdomen.The entire trocar was removed and a new one was opened and placed in patient's abdomen with no issues.Fda safety report id # (b)(4).Product not available for return.Additional information was received via email on 10-jan-2022 from user facility: a metal retractor was not used.There was no patient injury.An additional 5 mm trocar [non-applied] was used in the procedure.No damage to the tubing/balloon/balloon inflation port was noted.This was not a robotic procedure.No sharp instrument came into contact with the balloon.Type of intervention: the case was completed with a new trocar.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch# mw5105036.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: complaint created based on medwatch received by mail in 03jan2022.Report number mw5105036.The balloon broke while surgeon was manipulating the trocar in the patient's abdomen.The entire trocar was removed and a new one was opened and placed in patient's abdomen with no issues.Fda safety report id # (b)(4).Product not available for return.Additional information was received via email on 10jan2022 from user facility: a metal retractor was not used.There was no patient injury.An additional 5 mm trocar [non-applied] was used in the procedure.No damage to the tubing/balloon/balloon inflation port was noted.This was not a robotic procedure.No sharp instrument came into contact with the balloon.Type of intervention: the case was completed with a new trocar.Patient status: no patient injury.

• Brand Name: CFF73, 12X100 KII FIOS ADVFIX 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13237757
• Report Number: 2027111-2022-00316
• Device Sequence Number: 4610365
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)240128(30)01(10)1406410
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 01/28/2024
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1406410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM OPTIVIEW TROCAR
• Patient Sex: Unknown