MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB010, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: tah bso.Event description: it was used by one of our new consultants mr [] in theatre 1 doing a tah bso.The device stuck to the tissue and wouldn¿t open but there was no harm to the patient.Unfortunately the device was discarded.Additional information received via email from applied medical, 13 september: i've just been to the hospital and spoken to one of the staff members.The only clarification i received was, jaws locked in one position and they were unable to open it.It wasn't due to sticky tissues but rather a fault mechanical aspect on the handpiece.There was only one event and that's jaws locked in one position, not necessarily sticking but they couldn't pull it away from tissue.Am still waiting on the other answers as the staff weren't able to remember.They have emailed the surgeon to get more info.They have apologised for not being able to get any more details but have assured to keep me posted.Will let you know as soon as i gather more info.Patient status: no injury occured.
Event or Problem Description
Procedure performed: tah bso.Event description: it was used by one of our new consultants mr in theatre 1 doing a tah bso.The device stuck to the tissue and wouldn¿t open but there was no harm to the patient.Unfortunately the device was discarded.Additional information received via email from applied medical, 13 september: i've just been to the hospital and spoken to one of the staff members.The only clarification i received was, jaws locked in one position and they were unable to open it.It wasn't due to sticky tissues but rather a fault mechanical aspect on the handpiece.There was only one event and that's jaws locked in one position, not necessarily sticking but they couldn't pull it away from tissue.Am still waiting on the other answers as the staff weren't able to remember.They have emailed the surgeon to get more info.They have apologised for not being able to get any more details but have assured to keep me posted.Will let you know as soon as i gather more info.Patient status: no injury occured.
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.

• Brand Name: EB010, VOYANT 5MM FUSION 37CM, 6/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: 9104464
• Report Number: 2027111-2019-00594
• Device Sequence Number: 16588382
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)201027(30)01(10)1354486
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/23/2019

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: 10/27/2020
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1354486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1