MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF12, 5X100 KII FIOS ADVFIX DP 10/BX; GCJ

Model Number	CFF12, 5X100 KII FIOS ADVFIX DP 10/BX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
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: lap cholecystectomy.Event description: towards the end of the case, when the surgeon inserted the scope to do the final check, he noticed the instrument shield from the trocar was inside the patient.He has retrieved it.The nurse did note, there was an aspiration needle used for the gall bladder and initially it didn't go through initially on the first attempt.They stated it could be due to the needle but never had this experience before.Have isolated for return along with other trocars with the same lot number.Additional information received via adverse incident report, 7th february 2019: internal valve detached from black bung inside the sleeve of port and was found in abdominal cavity.The only instruments introduced into the port were a laparoscopic tissue forcep and a aspiration needle.There was a little resistance when trying to introduce the aspiration needle which is the only anomaly during a routine procedure.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier): internal valve removed from patient and port kept for analysis.Examination and comparison of the same 5 mm port to ensure all pieces were accounted for with scrub nurse, senior sister and consultant; lot numbers removed from stock room and isolated; discussed with staff at hand overs and briefings.Sister site informed.Patient status: patient is fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of seal component separation.The shield, a clear plastic component of the seal and the septum, a rubber internal component of the seal, were damaged.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrumentation through the trocar.Applied medical¿s instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: lap cholecystectomy.Event description: towards the end of the case, when the surgeon inserted the scope to do the final check, he noticed the instrument shield from the trocar was inside the patient.He has retrieved it.The nurse did note, there was an aspiration needle used for the gall bladder and initially it didn't go through initially on the first attempt.They stated it could be due to the needle but never had this experience before.Have isolated for return along with other trocars with the same lot number.Additional information received via adverse incident report, 7th february 2019: internal valve detached from black bung inside the sleeve of port and was found in abdominal cavity.The only instruments introduced into the port were a laparoscopic tissue forcep and a aspiration needle.There was a little resistance when trying to introduce the aspiration needle which is the only anomaly during a routine procedure.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) 1.Internal valve removed from patient and port kept for analysis.2.Examination and comparison of the same 5 mm port to ensure all pieces were accounted for with scrub nurse, senior sister and consultant; 3.Lot numbers removed from stock room and isolated; 4.Discussed with staff at hand overs and briefings.Sister site informed.Patient status: patient is fine.

• Brand Name: CFF12, 5X100 KII FIOS ADVFIX DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8376352
• Report Number: 2027111-2019-00362
• Device Sequence Number: 16715499
• Product Code: GCJ
• UDI-Device Identifier: 00607915124090
• UDI-Public: (01)00607915124090(17)210919(30)01(10)1337147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 09/19/2021
• Device Model Number: CFF12, 5X100 KII FIOS ADVFIX DP 10/BX
• Device Catalogue Number: 101452601
• Device Lot Number: 1337147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATION NEEDLE