MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2, GELPORT 120MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8XX2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
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 investigation.
Event or Problem Description
Procedure performed: laparoscopic hand assisted sigmoidectomy.Complaint 1 of 2: #2022-000889 (mfr # 2027111-2022-00542).Complaint 1 of 2: #2022-000890.Event description: "in both cases the gelport cap and attached alexis came out of the incision when the surgeon attempted to removed his hand through the cap.In the first case, this happened twice.In the second case, this happened once.There was no patient injury, current patient status unknown.Both cases continued with the same device.No other instruments were being used through the gel at the time of the event.The model of the gelport is c8xx2 (p/n 700314663), lot number 1433372.No product is available for return.Both gelports were brought in under a no charge scrub po." both cases were a laparoscopic hand assisted sigmoidectomy.Additional information received via email 25mar2022 from [name], associate clinical specialist: the products were disposed of before amr was made aware of the incidents.Alert date is 21mar2022.Products are not available for return.Patient status: there was no patient injury, current patient status unknown.Type of intervention: the case continued with the same device.
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-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event.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: laparoscopic hand assisted sigmoidectomy.Complaint 1 of 2: #: (b)(4)- mfr# 2027111-2022-00542, complaint 1 of 2: #: (b)(4)- mfr# 2027111-2022-00551.Event description: "in both cases the gelport cap and attached alexis came out of the incision when the surgeon attempted to removed his hand through the cap.In the first case, this happened twice.In the second case, this happened once.There was no patient injury, current patient status unknown.Both cases continued with the same device.No other instruments were being used through the gel at the time of the event.The model of the gelport is c8xx2 (p/n: 700314663), lot number: 1433372.No product is available for return.Both gelports were brought in under a no charge scrub po." both cases were a laparoscopic hand assisted sigmoidectomy.Additional information received via email 25mar2022 from [name], associate clinical specialist: the products were disposed of before amr was made aware of the incidents.Alert date is 21mar2022.Additional information received via email 26apr2022 from [name], associate clinical development specialist: incision size for procedure was 8cm.Products are not available for return.Patient status: there was no patient injury, current patient status unknown.Type of intervention: the case continued with the same device.

• Brand Name: C8XX2, GELPORT 120MM
• 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: 14079009
• Report Number: 2027111-2022-00551
• Device Sequence Number: 14774569
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)240229(30)01(10)1433372
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 02/29/2024
• Device Model Number: C8XX2
• Device Catalogue Number: 700314663
• Device Lot Number: 1433372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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