MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.The report is to follow up medwatch report (mw5079229).
Event or Problem Description
Name of procedure being performed: davinci robotic hernia lap repair.Event description: during surgery a piece of black rubber seal was found on top of the bowel.The surgeon removed it.The top of the trocar was removed and found that the piece matched the missing piece from the trocar.This was the port used for the davinci scope.This occurred at the end of the case and the case was completed with no patient injury.The device is available for return.Medwatch report (mw5079229) received via mail on (b)(6) 2018: at the end of robotic hernia repair, two pieces of black rubber noted on pts omentum visualized.Physician removed and irrigated abdomen to make sure no other pieces left.Black rubber pieces determined to have come from the black seal form the applied medical trocar.Dates of use: (b)(6) 2018.Diagnosis of reason for use: robotic lap hernia repair.Patient status: no patient injury occurred as a result of the event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a rubber fragment.Visual inspection confirmed the complainant's experience of seal component separation.The duckbill and the septum, two rubber components of the seal, were damaged.The rubber fragment completed the missing portion on the duckbill.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 instruments 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.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.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.The report is to follow up medwatch report (mw5079229).
Event or Problem Description
Name of procedure being performed: davinci robotic hernia lap repair.Event description: during surgery a piece of black rubber seal was found on top of the bowel.The surgeon removed it.The top of the trocar was removed and found that the piece matched the missing piece from the trocar.This was the port used for the davinci scope.This occurred at the end of the case and the case was completed with no patient injury.The device is available for return.Medwatch report (mw5079229) received via mail on sep 05, 2018: at the end of robotic hernia repair, two pieces of black rubber noted on pts omentum visualized.Physician removed and irrigated abdomen to make sure no other pieces left.Black rubber pieces determined to have come from the black seal form the applied medical trocar.Dates of use: (b)(6) 2018.Diagnosis of reason for use: robotic lap hernia repair.Patient status: no patient injury occurred as a result of the event.
Additional Manufacturer Narrative
Correction: updated g6 "type of report" to follow-up number 1 as this was documented as follow-up number 2 in medwatch # 00089 - mfr 2027111-2018-00348 and follow-up number 3 in medwatch # 04344.
Event or Problem Description
Name of procedure being performed: davinci robotic hernia lap repair.Event description: during surgery a piece of black rubber seal was found on top of the bowel.The surgeon removed it.The top of the trocar was removed and found that the piece matched the missing piece from the trocar.This was the port used for the davinci scope.This occurred at the end of the case and the case was completed with no patient injury.The device is available for return.Medwatch report (mw5079229) received via mail on sep 05, 2018: at the end of robotic hernia repair, two pieces of black rubber noted on pts omentum visualized.Physician removed and irrigated abdomen to make sure no other pieces left.Black rubber pieces determined to have come from the black seal form the applied medical trocar.Dates of use: (b)(6)2018.Diagnosis of reason for use: robotic lap hernia repair.Patient status: no patient injury occurred as a result of the event.
Additional Manufacturer Narrative
Correction: updated g6 "type of report" to follow-up number 1 as this was documented as follow-up number 2 in medwatch # 00089 - mfr 2027111-2018-00348.
Event or Problem Description
Name of procedure being performed: davinci robotic hernia lap repair.Event description: during surgery a piece of black rubber seal was found on top of the bowel.The surgeon removed it.The top of the trocar was removed and found that the piece matched the missing piece from the trocar.This was the port used for the davinci scope.This occurred at the end of the case and the case was completed with no patient injury.The device is available for return.Medwatch report (mw5079229) received via mail on sep 05, 2018: at the end of robotic hernia repair, two pieces of black rubber noted on pts omentum visualized.Physician removed and irrigated abdomen to make sure no other pieces left.Black rubber pieces determined to have come from the black seal form the applied medical trocar.Dates of use: (b)(6) 2018.Diagnosis of reason for use: robotic lap hernia repair.Patient status: no patient injury occurred as a result of the event.

• Brand Name: CFF71, 12X150 KII FIOS ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7865175
• Report Number: 2027111-2018-00348
• Device Sequence Number: 1703393
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)210315(30)01(10)1320445
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2018

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: 03/15/2021
• Device Model Number: CFF71
• Device Catalogue Number: 101255901
• Device Lot Number: 1320445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018; Not provided; 08/16/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/25/2023; 09/28/2018; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown