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	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy.Event description: in the surgery they were using applied medical kii z-thread trocars and other laparoscopic instruments such as lens, also a uterine manipulator was being used.The laparoscopic technician on the case mentions the voyant device apparently was activating by itself, when a seal was not desired, hence they stopped using the device.This device was opened once another voyant device failed.Product is available for return.Additional information received via email on 04mar2021 from applied medical sales representative: "the case was completed with the device having failures"."it [the unintended activation] occurred since the device was opened, without the need to activate it"."this happened during the whole procedure"" the issues occurred "since the beginning".Type of intervention: the procedure was completed with an open approach, since the device was failing.Patient status: good.
Event or Problem Description
Procedure performed: laparoscopic hysterectomy.Event description: in the surgery they were using applied medical kii z-thread trocars and other laparoscopic instruments such as lens, also a uterine manipulator was being used.The laparoscopic technician on the case mentions the voyant device apparently was activating by itself, when a seal was not desired, hence they stopped using the device.This device was opened once another voyant device failed.Product is available for return.Additional information received via email on 04mar2021 from applied medical sales representative: "the case was completed with the device having failures." "it [the unintended activation] occurred since the device was opened, without the need to activate it." "this happened during the whole procedure"" the issues occurred "since the beginning".Type of intervention: the procedure was completed with an open approach, since the device was failing patient status: good.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation testing was performed on the event unit; however, the complainant's experience could not be replicated.There were no anomalies that could have resulted in unintended device activation.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 11532314
• Report Number: 2027111-2021-00399
• Device Sequence Number: 17130043
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)210714(30)01(10)1379432
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 07/14/2021
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1379432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR