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

Model Number	EB010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience.Engineering observed that the trigger lock, a metal component located at the bottom of the trigger, was deformed.Based on the condition of the returned unit, it is likely that the reported event was caused by deformation of the trigger lock, which is used to engage and disengage the trigger from the handle.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented component enhancements intended to further minimize the potential for this type of event to occur.This report reflects the combined initial and final report.
Event or Problem Description
Procedure performed: total laparoscopic hysterectomy.First evaluation case wit dr (obgyn) of voyant eb010.Product had been correctly in serviced prior to case.Approximately 15 activations into procedure the spring loaded handle would not release immediately after activation and transaction.I was approximately 2 meters from the incident and had a perfect view - to this point the device was working exactly as expected yet on this cycle the patients tissue bundle remained grasped between the jaws.Assessment is that the spring handle failed.This incident required the surgeon to use scissors to extract the tissue - a replacement voyant eb010 from the same batch was opened the case proceeded without incident.Surgeon commented positively on the device functionality but the incident caused some understandable concern.Additional info received from applied medical team member, (b)(6): dr was taking down the ip ligament when the event occurred.Patient status: did a patient injury or illness occur associated with the complaint event? no.Patient status (what happened as a result of this event?): short delay to progress.Replacement opened & case proceeded without incident.

• 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: 7325975
• Report Number: 2027111-2018-00104
• Device Sequence Number: 104286
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)181005(30)01(10)1293851
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 03/08/2018

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: Physician
• Device Expiration Date: 10/05/2018
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1293851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/08/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1