MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR33, 11X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: laparoscopic cholecystectomy.Event description: "a free floating piece was noted in the abdomen it was secured on the sterile field when trocar was removed from patient a search was done for additional pieces.2 total pieces were taken from patient." product is available for return.Additional information received via email 16nov2021 from user facility: it is unknown when the incident occurred.The procedure performed was laparoscopic cholecystectomy.There are no pictures available for the device.Additional information received via email 16nov2021 from user facility: it is unsure if direct pressure or rotation was used during insertion.No difficulty was reported with insertion.Customer states that only a small section broke on the end of the trocar.The two pieces that were recovered seemed to be all that broke off the trocar.The patient's abdominal cavity was examined for any other pieces.The trocar was not used with a robot.An atraumatic bowel grasper was used with this trocar.Maryland dissector, scissors, and clip applier was also used in the case."case was completed laparoscopically, patient condition was stable when they left or.So far no return procedures." intervention: "2 total pieces were taken from patient" and "case was completed laparoscopically" patient status: "patient condition was stable when they left or.So far no return procedures.".
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: "a free floating piece was noted in the abdomen it was secured on the sterile field when trocar was removed from patient a search was done for additional pieces.2 total pieces were taken from patient." product is available for return.Additional information received via email (b)(6) 2021 from user facility: it is unknown when the incident occurred.The procedure performed was laparoscopic cholecystectomy.There are no pictures available for the device.Additional information received via email (b)(6) 2021 from user facility: it is unsure if direct pressure or rotation was used during insertion.No difficulty was reported with insertion.Customer states that only a small section broke on the end of the trocar.The two pieces that were recovered seemed to be all that broke off the trocar.The patient's abdominal cavity was examined for any other pieces.The trocar was not used with a robot.An atraumatic bowel grasper was used with this trocar.Maryland dissector, scissors, and clip applier was also used in the case."case was completed laparoscopically, patient condition was stable when they left or.So far no return procedures." intervention: "2 total pieces were taken from patient" and "case was completed laparoscopically" patient status: "patient condition was stable when they left or.So far no return procedures.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with two fragments.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.The fragments completed the missing portion of the cannula tip.Based on the condition of the returned unit and the description of the event, it is possible that the cannula tip fractured due to a large force exerted on it or an instrumentation coming in contact with it during the procedure.It is also possible that the cannula 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.

• Brand Name: CFR33, 11X100 KII OPT 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: 12846321
• Report Number: 2027111-2021-00732
• Device Sequence Number: 4093767
• Product Code: GCJ
• UDI-Device Identifier: 00607915123222
• UDI-Public: (01)00607915123222(17)240513(30)01(10)1415782
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/11/2022

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: 05/13/2024
• Device Model Number: CFR33
• Device Catalogue Number: 101245801
• Device Lot Number: 1415782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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