MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EA010, VOYANT GENERATOR, 1/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EA010
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
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 submitted upon completion of investigation.
Event or Problem Description
Procedure performed: lavth.Event description: the rep was not present during the case.The generator was turned on and worked fine at sealing tissue during the case.However, there was no audio cues from the generator.The generator was unplugged and re-plugged into the power source and was inserted into a different power source, but it did not resolve the audio issue.The device key was removed and re-inserted into the generator with no effect on the audio issues.No audio cues were given for either the eb040 or the eb015 that were used with the generator.No patient injury.Product is available for return.Patient status: no patient injury.
Event or Problem Description
Procedure performed: lavth.Event description: the rep was not present during the case.The generator was turned on and worked fine at sealing tissue during the case.However, there was no audio cues from the generator.The generator was unplugged and re-plugged into the power source and was inserted into a different power source, but it did not resolve the audio issue.The device key was removed and re-inserted into the generator with no effect on the audio issues.No audio cues were given for either the eb040 or the eb015 that were used with the generator.No patient injury.Product is available for return.Additional information received via email on 07oct2020 from applied medical account manager: "but the case was finished successfully with no harm to the patient.They only have one generator so had a nurse come in the room and tell the surgeon every time the seal cycle completed." 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, which confirmed that the unit was unable to produce any noise/audio.Based on the evaluation of the returned unit, the event unit was unable to produce any noise/audio due to a defective speaker.The probability and criticality of harm resulting from this failure have been evaluated and were found to be an acceptable level.

• Brand Name: EA010, VOYANT GENERATOR, 1/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: 10601755
• Report Number: 2027111-2020-00570
• Device Sequence Number: 14357524
• Product Code: GEI
• UDI-Device Identifier: 00607915131371
• UDI-Public: (01)00607915131371(17)190128(30)01(10)1348112
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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 Model Number: EA010
• Device Catalogue Number: 101376401
• Device Lot Number: 1348112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EB040 AND EB015