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

Model Number	EB010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Translation ame: the handle blocked during the gesture, entailing tearing of tissue and bleeding.Remedial actions: use of another device of another brand to finish the procedure additional information received 27nov2018: current patient status? the patient is fine.Approximate amount of blood lost (in cc or cl)? not a lot.How long had the device been used before the experience was observed (approx.# of activations)? 3 or 4 activations.How was the bleeding resolved? by coagulation with a bi-polaire.Did the surgeon attempt to open the jaws, or did they pull the jaws off straight away? the surgeon tried to open the jaws but it wasn't possible.In which position was the blade lever when the incident occurred? the surgeon doesn't know where the blade lever was but the incident occurred after the coagulation.What tissue type did the jaws stay closed on? on the round ligament.Additional information received 14dec2018: the surgeon pulled on the jaws and removed from the patient.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a locked handle.Engineering observed that the jaws were in the locked position and the blade lever was disengaged from the blade button.Based on the condition of the returned unit, the reported event was caused by the disengagement of the blade lever from the blade button.The disengaged blade button blocked the trigger handle and prevented the jaws from opening, which caused the jaws to be locked.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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
Procedure performed: unknown.Original: blocage de la poignée au moment du geste entrainant un arrachement des tissus et des saignements.Action menée : utilisation d¿un autre dispositif d¿une autre marque pour terminer l¿intervention.Translation ame: the handle blocked during the gesture, entailing tearing of tissue and bleeding.Remedial actions: use of another device of another brand to finish the procedure.Additional information received 27nov2018: current patient status? the patient is fine.Approximate amount of blood lost (in cc or cl)? not a lot.How long had the device been used before the experience was observed (approx.# of activations)? 3 or 4 activations.How was the bleeding resolved? by coagulation with a bi-polaire.Did the surgeon attempt to open the jaws, or did they pull the jaws off straight away? the surgeon tried to open the jaws but it wasn¿t possible.In which position was the blade lever when the incident occurred? the surgeon doesn¿t know where the blade lever was but the incident occurred after the coagulation.What tissue type did the jaws stay closed on? on the round ligament.Additional information received 14dec2018: the surgeon pulled on the jaws and removed from the patient.Patient status: fine.

• Brand Name: EB010
• Common Device Name: EB010, VOYANT 5MM FUSION 37CM, 6/BX
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8182783
• Report Number: 2027111-2018-00484
• Device Sequence Number: 2106017
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190707(30)01(10)1314880
• 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): 01/18/2019

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: 07/07/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1314880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/18/2019
• Patient Sequence Number: 1