MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8501
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
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 provided upon completion of the investigation.
Event or Problem Description
Procedure performed: robotic sigmoidectomy event description: two complaints occurred in the same case.Complaint 1 of 2: #(b)(6), complaint 2 of 2: #(b)(6).Field team was not present during device use.The first c8501 was placed within patient and approximately 30 minutes after deployment, the surgical team found that the sheath was separated from the green inner ring and a portion of the ring was hanging inside the patient.A second c8501 was used and the sheath separated from the green inner ring again 30 minutes after deployment, similar to the first c8501.The case was completed with the third c8501.No patient injury occurred.The surgical team also note that they would pull off looped cord from device before use, using the same procedure for 15 years.Images of devices are available products are available for return.Additional information received on 02jun2022 via email from account manager.The green placement ring detached from the sheath 30 minutes after deployment for both devices.Patient status: no patient injury.Type of intervention: case was completed with the third device.
Event or Problem Description
Procedure performed: robotic sigmoidectomy.Event description: two complaints occurred in the same case.Complaint 1 of 2: #(b)(4) - mfr# 2027111-2022-00636.Complaint 2 of 2: #(b)(4) - mfr# 2027111-2022-00637.Field team was not present during device use.The first c8501 was placed within patient and approximately 30 minutes after deployment, the surgical team found that the sheath was separated from the green inner ring and a portion of the ring was hanging inside the patient.A second c8501 was used and the sheath separated from the green inner ring again 30 minutes after deployment, similar to the first c8501.The case was completed with the third c8501.No patient injury occurred.The surgical team also note that they would pull off looped cord from device before use, using the same procedure for 15 years.Images of devices are available products are available for return.Additional information received on 02jun2022 via email from account manager.The green placement ring detached from the sheath 30 minutes after deployment for both devices.Patient status: no patient injury.Type of intervention: case was completed with the third device.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, confirming complainant¿s experience of the sheath had separated from the inner ring.Based on the description of the event and the photos provided, it is possible that the reported event was caused by a weak or incomplete heat seal between the sheath and the inner ring.However, this could not be confirmed as the event unit was not returned.

• Brand Name: C8501, S ALEXIS LAP SYS 6/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• 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: 14748720
• Report Number: 2027111-2022-00636
• Device Sequence Number: 4793315
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)250310(30)01(10)1444854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: 03/10/2025
• Device Model Number: C8501
• Device Catalogue Number: 101042501
• Device Lot Number: 1444854
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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