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

Model Number	EB010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, however, a piece of the event unit was not returned.Visual inspection confirmed the complainant¿s experience of a device breakage.Based on the condition of the partial unit that was returned, the 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.This documents reflects both the initial and final report.
Event or Problem Description
Procedure performed: tlh towards the end of the case doctor was grasping the cardinal ligament when he went to close the device, the jaw broke off and was dangling by the wire.5mm trocar was being used so the device had to be cut and pulled out.Doctor reported to the rep that the patient¿s endometrial tissue wasn¿t bad.A new device was opened and the case was completed.Additional information received (b)(6) 2018: i am not sure i can reach out to the surgeon and ask for more clarification.What i was told was they had to cut the wire in order to get the jaw out of the trocar because they were just using 5 mm trocars.Additional information received (b)(6) 2018: they did confirm there were no abnormalities with that case.Patient status: no patient injury.

• 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: 8218856
• Report Number: 2027111-2019-00309
• Device Sequence Number: 1657227
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)200108(30)01(10)1329263
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 01/08/2020
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1329263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/04/2019
• Patient Sequence Number: 1