MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CY010, 5MMX35CM EPIX LAPA DISSECT, 10/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CY010
Medical Device Problem Codes	Activation Failure (3270); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: the acct mgr was not present for the case.The cautery function did not work from the beginning.It is unknown what monopolar cord was used.A new device was opened and used to complete the case.The cord was able to be attached to the device.It is unknown if the cable was replaced with the alternate device.There was no patient injury.There are no photos available.The device is available to be returned.Intervention: a new device was opened and use to complete the case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit; however, the complainant¿s experience could not be confirmed as the event unit functioned as intended.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.
Event or Problem Description
Procedure performed: unknown.Event description: the acct mgr was not present for the case.The cautery function did not work from the beginning.It is unknown what monopolar cord was used.A new device was opened and used to complete the case.The cord was able to be attached to the device.It is unknown if the cable was replaced with the alternate device.There was no patient injury.There are no photos available.The device is available to be returned.Intervention: a new device was opened and use to complete the case.Patient status: no patient injury.

• Brand Name: CY010, 5MMX35CM EPIX LAPA DISSECT, 10/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12155615
• Report Number: 2027111-2021-00569
• Device Sequence Number: 19824963
• Product Code: GEI
• UDI-Device Identifier: 00607915126964
• UDI-Public: (01)00607915126964(17)240322(30)01(10)1411723
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 03/22/2024
• Device Model Number: CY010
• Device Catalogue Number: 101419901
• Device Lot Number: 1411723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1