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	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: robot lobectomy.Event description: the rep was not present during the case.During the case, parts of the seal became dislodged and fell into the patient.The surgical team initially found a black piece of the seal inside the patient.When the surgical staff went to retrieve the piece from the patient they also found a clear piece from the trocar seal that was within the patient.Both pieces were successfully retrieved from the patient.The black piece appeared to have been a piece of a seal component and not an entire component.It is unknown if the clear piece was the entire shield or just a fragment.This procedure used a da vinci robot but it is unknown what other instruments were used in the case or what actions were being performed when the pieces of the seal fell into the patient.No patient injury.No product return.Product was disposed of by the facility.Additional information received via email on 07oct2021 from applied medical account manager: "i talked to the scrub nurse.She said the case was a lobectomy and the doctor had only put surgical patty¿s through the trocar and had done 10 or so exchanges through it when they noticed the black seal in the patient cavity.They removed the black piece, placed another trocar.Completed the case and when they were doing a final look through that is when they noticed the clear piece near the diaphragm." type of intervention: seal material were retrieved from the patient.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, confirming the complainant¿s experience.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: robot lobectomy.Event description: the rep was not present during the case.During the case, parts of the seal became dislodged and fell into the patient.The surgical team initially found a black piece of the seal inside the patient.When the surgical staff went to retrieve the piece from the patient they also found a clear piece from the trocar seal that was within the patient.Both pieces were successfully retrieved from the patient.The black piece appeared to have been a piece of a seal component and not an entire component.It is unknown if the clear piece was the entire shield or just a fragment.This procedure used a da vinci robot but it is unknown what other instruments were used in the case or what actions were being performed when the pieces of the seal fell into the patient.No patient injury.No product return.Product was disposed of by the facility.Additional information received via email on (b)(6) 2021 from applied medical account manager: "i talked to the scrub nurse.She said the case was a lobectomy and the doctor had only put surgical patty¿s through the trocar and had done 10 or so exchanges through it when they noticed the black seal in the patient cavity.They removed the black piece, placed another trocar.Completed the case and when they were doing a final look through that is when they noticed the clear piece near the diaphragm." type of intervention: seal material were retrieved from the patient.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: 12616523
• Report Number: 2027111-2021-00663
• Device Sequence Number: 19150153
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)240607(30)01(10)1416640
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/07/2021

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: 06/07/2024
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1416640
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: DAVINCI ROBOT
• Patient Sex: Unknown