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

Model Number	C8XX2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap hand assist colon resection.Event description: c8xx2 malfunctioned.Additional information received on 27sep2022 via email from [name], materials manager: "ripped while using".No injuries related to the reported concern.Additional information received on 28sep2022 via email from [name], materials manager.: the alexis sheath tore.The surgeon's hand was cupped appropriately and inserted into the device at the time of tear.The alexis sheath was torn from white to green all the way through.The surgeon removed torn sheath and opened another sheath to complete the case.Additional information received on 29sep2022 via email from [name]: product is available for return.Patient status: no injuries related to the reported concern.Type of intervention: the surgeon removed torn sheath and opened another sheath to complete the case.
Event or Problem Description
Procedure performed: lap hand assist colon resection.Event description: c8xx2 malfunctioned.Additional information received on 27sep2022 via email from [name], materials manager: "ripped while using." no injuries related to the reported concern.Additional information received on 28sep2022 via email from [name], materials manager.: the alexis sheath tore.The surgeon's hand was cupped appropriately and inserted into the device at the time of tear.The alexis sheath was torn from white to green all the way through.The surgeon removed torn sheath and opened another sheath to complete the case.Additional information received on 29sep2022 via email from [name]: product is available for return.Patient status: no injuries related to the reported concern.Type of intervention: the surgeon removed torn sheath and opened another sheath to complete the case.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of sheath tear.Based on the condition of the returned unit, it is likely that an object or instrument came in contact with the sheath, resulting in a tear or hole.As the sheath experiences stresses during use, it is possible that the hole or tear propagated through the sheath.

• 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: 15583656
• Report Number: 2027111-2022-00770
• Device Sequence Number: 12358759
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)240331(30)01(10)1450700
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: 03/31/2024
• Device Model Number: C8XX2
• Device Catalogue Number: 700314608
• Device Lot Number: 1450700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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