MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF03
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: diagnostische lsk.[translation] tip of the obturator is broken and the shaft of the trocar is kinked.Breakage in the area of the kink in the upper part of the shaft.Patient status: patient is ok.
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: diagnostische lsk.Event description: [translation] tip of the obturator is broken and the shaft of the trocar is kinked.Breakage in the area of the kink in the upper part of the shaft.Patient status: patient is ok.
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 cannula and obturator was more susceptible to breakage.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: updated component codes to 4742 - inserter and device codes to 1260 - fracture.

• Brand Name: CFF03, 5X100 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: 15123023
• Report Number: 2027111-2022-00673
• Device Sequence Number: 5647062
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)250428(30)01(10)1448438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/07/2022

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: 04/28/2025
• Device Model Number: CFF03
• Device Catalogue Number: 101473818
• Device Lot Number: 1448438
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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