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	02/16/2018
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: laparoscopy.Hospital file number; (b)(4).The device did not want to open anymore during a laparoscopy.Blocked in closed position.Non-functional blade as well.Reopens once removed from the abdomen.Risk of tearing issue with bleeding.Patient status: clinical consequences: none.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual and mechanical testing was performed on the event unit.However, the complainant's experience of a non-functional jaw and blade could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.Although the exact root cause of the reported event could not be determined, 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: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7399468
• Report Number: 2027111-2018-00136
• Device Sequence Number: 11067908
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190416(30)01(10)1307979
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/20/2018

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: Other
• Device Expiration Date: 04/16/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1307979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 04/20/2018
• Patient Sequence Number: 1