MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R37
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lobectomy.Event description: limited information is available at the time of report.Rep was not present for the case.Surgeon stated that pieces of the trocar were falling off into the patient during the procedure.Additional information was received via email on 03feb2022 from applied medical account manager: there was no patient injury.The case was completed with a new trocar.A babcock with a sponge on it was being inserted into the trocar at the time of the event.The procedure being performed was a lobectomy.The entire clear/white seal component fell into the patient.All pieces were retrieved from the patient.No internal seal components were removed or cut in order to inspect the damaged component.Product is available for return.It is unknown if they will be returning the units.Type of intervention: the case was completed with a new trocar.Patient status: no patient injury.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformance's that could have contributed to the reported event of shield dislodgement.Based on 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 (ifu) 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.".
Event or Problem Description
Procedure performed: lobectomy.Event description: limited information is available at the time of report.Rep was not present for the case.Surgeon stated that pieces of the trocar were falling off into the patient during the procedure.Additional information was received via email on 03feb2022 from applied medical account manager: there was no patient injury.The case was completed with a new trocar.A babcock with a sponge on it was being inserted into the trocar at the time of the event.The procedure being performed was a lobectomy.The entire clear/white seal component fell into the patient.All pieces were retrieved from the patient.No internal seal components were removed or cut in order to inspect the damaged component.Product is available for return.It is unknown if they will be returning the units.Additional information was received via email on 11feb2022 from applied medical account manager: the entire white seal fell down the trocar.Type of intervention: the case was completed with a new trocar.Patient status: no patient injury.

• Brand Name: C0R37, 15X100 KII OPT ZTHR 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: 13488603
• Report Number: 2027111-2022-00355
• Device Sequence Number: 20136441
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)241025(30)01(10)1428789
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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): 04/13/2022

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: 10/25/2024
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1428789
• Was Device Available for Evaluation?: No
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BABCOCK WITH A SPONGE ON IT
• Patient Sex: Unknown