MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF12, 5X100 KII FIOS ADVFIX DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF12
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: translation: the operating room had a problem yesterday with a broken obturator tip on reference cff12 lot 1428854.No patient incidence, the material has been changed.It is available for return, for expertise.Additional information received by email from applied medical representative on 14 apr 2022: dr.Introduced his trocar and on contact with the tissues the end of it broke.He changed his trocar and was able to operate on his patient without any problem.Intervention: change of device.Patient status: no patient injury or illness occur associated with the complaint event.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: translation: the operating room had a problem yesterday with a broken obturator tip on reference cff12 lot 1428854.No patient incidence, the material has been changed.It is available for return, for expertise.Original: le bloc a eu un problème hier d¿embout de mandrin cassé sur la référence cff12 lot 1428854.Aucune incidence patient, le matériel a été changé.Il est disponible pour reprise, pour expertise.Additional information received by email from applied medical representative on 14apr22: dr.[name] introduced his trocar and on contact with the tissues the end of it broke.He changed his trocar and was able to operate on his patient without any problem additional information received by email from applied medical representative on 14apr22: the break was considered to be a clean break.No pieces fell into the patient.It seems that during the 1st pressure exerted on the wall the trocar broke.There was no difficulty during insertion, the breakage occured too quickly.This was not a robotic case.Intervention: change of device.Patient status: no patient injury or illness occur associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured obturator.The event unit contained a clean obturator shaft fracture.Based on the condition of the returned unit, it is likely that the obturator was more susceptible to breakage.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as a clean obturator shaft fracture is unlikely to cause or contribute to death or serious injury.Correction [h6]: component code has been changed to "4742 - inserter" and device code has been changed to "1069 - break".

• Brand Name: CFF12, 5X100 KII FIOS ADVFIX DP 10/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: 14190915
• Report Number: 2027111-2022-00573
• Device Sequence Number: 17282270
• Product Code: GCJ
• UDI-Device Identifier: 00607915124090
• UDI-Public: (01)00607915124090(17)241005(30)01(10)1428854
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 10/05/2024
• Device Model Number: CFF12
• Device Catalogue Number: 101473832
• Device Lot Number: 1428854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/22/2022
• Date Device Manufactured: 10/06/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose