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	05/11/2022
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 colectomy.Similar c8501 malfunctions occurred in 3 cases.Complaint 1 of 3: #(b)(4).Complaint 2 of 3: #(b)(4).Complaint 3 of 3: #(b)(4) product returning.Event description: event date was sometime in the past week.C8501 was placed within patient with 12mm trocar and no sharp instruments inserted.Approximately 1 hour into the case, the surgical team heard leaking and found that the sheath was separated from the green inner ring.A portion of the ring was hanging freely from the sheath inside the patient.A new device was opened to complete the case.No patient injury occurred.Product is not available for return.Patient status: no patient injury occurred.Type of intervention: a new device was opened to complete the case.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the sheath had separated from the inner ring.Based on the condition of the returned unit, it is possible that the reported event was caused by a weak or incomplete heat seal between the sheath and the inner ring.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: robotic colectomy.Similar c8501 malfunctions occurred in 3 cases.Complaint 1 of 3: #(b)(4) [mfr# 2027111-2022-00617].Complaint 2 of 3: #(b)(4) [mfr# 2027111-2022-00618].Complaint 3 of 3: #(b)(4).Event description: event date was sometime in the past week.C8501 was placed within patient with 12mm trocar and no sharp instruments inserted.Approximately 1 hour into the case, the surgical team heard leaking and found that the sheath was separated from the green inner ring.A portion of the ring was hanging freely from the sheath inside the patient.A new device was opened to complete the case.No patient injury occurred.Product is not available for return.Additional information received on 11may2022 via email from [name], account manager.Images of complaint device attached.Additional information received on 12may2022 via email from [name], account manager.Images are related to complaint #(b)(4).Additional information received on 28jun2022 via phone call from [name], account manager.Customer returned 3 units of c8501 for complaint #(b)(4).Patient status: no patient injury occurred.Type of intervention: a new device was opened to complete the case.

• 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: 14581973
• Report Number: 2027111-2022-00619
• Device Sequence Number: 2058141
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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?: Device Returned to Manufacturer
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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