MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown event description: the event date is unknown.Long time voyant users, usage as intended.Jaws did not open (inside nor outside the patient).Additional information received by applied medical rep via email on 3apr24: they were unable to open the jaws.The jaws were locked on tissue and they used a different voyant to dissect the locked one.Normal laparoscopic instruments and generator used during procedure.Type of intervention: device replacement.Patient status: no clinical impact to the patient has been reported.
Additional Manufacturer Narrative
The event unit will not returning to applied medical for evaluation, but a lot number was provided.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: unknown.Event description: the event date is unknown.Long time voyant users, usage as intended.Jaws did not open (inside nor outside the patient).Additional information received by applied medical rep via email on 3apr24: they were unable to open the jaws.The jaws were locked on tissue and they used a different voyant to dissect the locked one.Additional information received by applied medical rep via email on 25apr24: laparascopic hysterectomy (same surgery as in complaint form (b)(4)).All answer is the same as in complaint form (b)(4).(patiënt is ok.The blade was not visible.They used a different clamp to close the jaws.No tissue damage.No tissue bleeding.I happened at the start of the procedure.The jaws were closed using fenestrated grasper.It was observed twice).They replaced 2 devices with the exact same problems.Normal laparoscopic instruments and generator used during procedure.Type of intervention: device replacement.Patient status: no clinical impact to the patient has been reported.

• Brand Name: EB210, 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
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19217558
• Report Number: 2027111-2024-00611
• Device Sequence Number: 8194212
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)260330(30)01(10)1484982
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K201212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 03/30/2026
• Device Model Number: EB210
• Device Catalogue Number: 101476432
• Device Lot Number: 1484982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; LAP INSTRUMENTS
• Patient Sex: Unknown