MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR74, 12X100 KII OPT ADVFIX HDL 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR74
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: when the trocar was used a portion of the inside of the trocar came off on the inside of the trocar.Additional information received via email 30mar2022 from applied medical customer relations representative: customer from (b)(6) medical center called to report they could not visualize through the trocar.Additional information received via email 01apr2022 from the facility: customer confirmed there is only one cfr74 lot #1425182 complaint from the facility.Product was picked up by applied field team.Additional information received via email 07apr2022 from the facility: surgical tech reports inserting scope to be difficult at times.While inserting the scope a piece of the cannula/introducer chipped off and fell down in to the tip of the trocar resulting in decreased view.Reported to be small plastic piece (believe to be cannula/introducer not seal fragment).No injury to report.Used another cfr74 trocar to complete the case.10mm scope was inside of the cannula at the time of the incident.Lot traces to 1003630.Product is available for return.Type of intervention: used another cfr74 trocar to complete the case.Patient status: no injury to report.
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: unknown.Event description: when the trocar was used a portion of the inside of the trocar came off on the inside of the trocar.Additional information received via email 30mar2022 from applied medical customer relations representative: customer from lexington medical center called to report they could not visualize through the trocar.Additional information received via email 01apr2022 from the facility: customer confirmed there is only one cfr74 lot #1425182 complaint from the facility.Product was picked up by applied field team.Additional information received via email 07apr2022 from the facility: surgical tech reports inserting scope to be difficult at times.While inserting the scope a piece of the cannula/introducer chipped off and fell down in to the tip of the trocar resulting in decreased view.Reported to be small plastic piece (believe to be cannula/introducer not seal fragment).No injury to report.Used another cfr74 trocar to complete the case.10mm scope was inside of the cannula at the time of the incident.Lot traces to 1003630.The product is available for return.Type of intervention: used another cfr74 trocar to complete the case.Patient status: no injury to report.
Additional Manufacturer Narrative
A portion of the event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a damaged obturator.The clear fragment was identified to be a portion of the obturator shaft contained within the obturator.Based on the condition of the returned unit, it is most likely that a protruding piece of the obturator fragmented due to the insertion of the scope.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 an obturator fragment contained within the obturator is unlikely to cause or contribute to death or serious injury.

• Brand Name: CFR74, 12X100 KII OPT ADVFIX HDL 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: 14060764
• Report Number: 2027111-2022-00549
• Device Sequence Number: 19993910
• Product Code: GCJ
• UDI-Device Identifier: 00607915125745
• UDI-Public: (01)00607915125745(17)240811(30)01(10)1425182
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: 08/11/2024
• Device Model Number: CFR74
• Device Catalogue Number: 101470936
• Device Lot Number: 1425182
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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: Unknown