MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EA020, VOYANT GENERATOR, 1/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EA020
Medical Device Problem Codes	Energy Output Problem (1431); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hysterectomy.Event description: we had our new generator in the hospital after replacing the old version in different departments.We noticed complains mainly from the ob/gyn department that the open voyant eb240 heats up a lot and causing harmful thermal spread.After attending a case with the surgeon and seeing the unusual thermal spread we decided to change the generator.We tried a different generator and the problem was solved.Kindly note that the generator didn't give any alarm or an error was displayed.Additional information provided by applied lebanon via email 06oct2021: no patient injury.4-5 handpieces that were used with the generator.The generator wasn¿t giving an error, there was an unusual thermal spread that the surgeon noticed and called us in.No error code displayed, after we realized the thermal spread that was occurring only in the ob/gyn service we decided to try using a different generator.After replacing the generator the thermal spread decreased.No handpieces to return.Type of intervention: change of device.Patient status: no patient injury.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and applied medical was unable to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has review the details surrounding the event and is unable to determine the root cause of the event.The probability and criticality of the harm resulting from this failure have ben evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: hysterectomy.Event description: we had our new generator in the hospital after replacing the old version in different departments.We noticed complains mainly from the ob/gyn department that the open voyant eb240 heats up a lot and causing harmful thermal spread.After attending a case with the surgeon and seeing the unusual thermal spread we decided to change the generator.We tried a different generator and the problem was solved.Kindly note that the generator didn't give any alarm or an error was displayed.Additional information provided by applied lebanon via email 06oct21: no patient injury.4-5 handpieces that were used with the generator.The generator wasn't giving an error, there was an unusual thermal spread that the surgeon noticed and called us in.No error code displayed, after we realized the thermal spread that was occurring only in the ob/gyn service we decided to try using a different generator.After replacing the generator the thermal spread decreased.No handpieces to return.Type of intervention: change of device.Patient status: no patient injury.
Event or Problem Description
Procedure performed: hysterectomy.Event description: we had our new generator in the hospital after replacing the old version in different departments.We noticed complains mainly from the ob/gyn department that the open voyant eb240 heats up a lot and causing harmful thermal spread.After attending a case with the surgeon and seeing the unusual thermal spread we decided to change the generator.We tried a different generator and the problem was solved.Kindly note that the generator didn't give any alarm or an error was displayed.Additional information provided by applied lebanon via email 06oct21: no patient injury.4-5 handpieces that were used with the generator.The generator wasn¿t giving an error, there was an unusual thermal spread that the surgeon noticed and called us in.No error code displayed, after we realized the thermal spread that was occurring only in the ob/gyn service we decided to try using a different generator.After replacing the generator the thermal spread decreased.No handpieces to return.Additional information provided by applied lebanon via email 03nov21: this has occurred 4-5 times.No other incidents of thermal spread have been reported previously.Yes, there are eb240 devices available for return.Type of intervention: change of device patient status: no patient injury.
Additional Manufacturer Narrative
The generator unit was returned to applied medical for evaluation, without the handpieces that were used in conjunction with the generator.Testing was performed on the generator unit, and the unit functioned as intended.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: EA020, 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12701285
• Report Number: 2027111-2021-00688
• Device Sequence Number: 4028938
• Product Code: GEI
• UDI-Device Identifier: 00607915137601
• UDI-Public: (01)00607915137601(11)200113(30)01(10)1378847
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K182244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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 Model Number: EA020
• Device Catalogue Number: 101470971
• Device Lot Number: 1378847
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/04/2022; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EB240
• Patient Sex: Unknown