MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB010, VOYANT 5MM FUSION 37CM, 6/BX; GEI

Model Number	EB010
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: unknown.Following a meeting with theatre manager on 9th november 2018, i was informed that the patient from previous incident was returned to theatre following procedure on (b)(6) 2018.This was recorded via datix.Theatre manager did not provide further details when asked regarding circumstances of patients return to theatre.Patient status is unknown.Additional information has been requested but as of today, 19 november, it was not possible to gather more.Patient status: unknown.
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 the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Date of incident is unknown.Following a meeting with theatre manager, on 9th november 18, i was informed that the patient from previous incident was returned to theatre following procedure on (b)(6) 2018.This was recorded via datix.Theatre manager did not provide further details when asked regarding circumstances of patients return to theatre.Patient status is unknown additional information has been requested but as of today, 19 november, it was not possible to gather more.Clarification from rep received 17dec2018: the answer to your question; according to the information given to me by the theatre manager, on the 8th november 2018.Following the procedure on (b)(6) 2018, that patient returned back to theatre soon after (i don¿t know the date) for an unspecified reason.Theatre manager told me that he had heard a comment from hospital rep that implied it was due to the voyant.Because of this comment, i submitted a cer to report the additional information.

• Brand Name: EB010, VOYANT 5MM FUSION 37CM, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8158381
• Report Number: 2027111-2018-00465
• Device Sequence Number: 244082
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190817(30)01(10)1317789
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1317789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization