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	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: total laparoscopic colectomy.Event description: we would like to share with the team one cer occurred on (b)(6) 2020 at [hospital] through our customer.The complaint is about handpiece of voyant generation i (eb010) batch 1365170.The generator use was the serial number (b)(4).The procedure was due to cancer at two different sites.During the procedure was utilize laparoscopic surgery instruments such as lenses, instruments and trocars, the patient shows the following comorbidities at the time of surgery anemia, cirrhosis, high blood pressure.At the end of the surgery, the patient's health is good not injure occur a cause of the eb010 complaint.Dr.[name] can provide us a video as evidence of the failure.The eb010 is available to return.The procedure had been going for about 1 hour when they were performing some seals and had no signs of energy or heat dissipation, they made another seal and the surgeons noticed the same it was making the whole cycle and no alarms were presented, but there was no seal performance at all, they activated the blade and had some bleedings.The technician at the site restarted the generator and changed the device form port 1 to 2, but the lack of seal continued.So they opened a 2nd device, same lot number and worked well.The surgeon offered to give us a copy of the video.Type of intervention: they opened a 2nd device, same lot number and worked well.Patient status: at the end of the surgery, the patient's health is good not injure occur a cause of the eb010 complaint.
Event or Problem Description
Procedure performed: total laparoscopic colectomy.Event description: we would like to share with the team one cer occurred on (b)(6) 2020 at [hospital] through our customer.The complaint is about handpiece of voyant generation i (eb010) batch 1365170.The generator use was the serial number (b)(6).The procedure was due to cancer at two different sites.During the procedure was utilize laparoscopic surgery instruments such as lenses, instruments and trocars, the patient shows the following comorbidities at the time of surgery: anemia; cirrhosis; high blood pressure.At the end of the surgery, the patient's health is good not injure occur a cause of the eb010 complaint.Dr.[name] can provide us a video as evidence of the failure.The eb010 is available to return.The procedure had been going for about 1 hour when they were performing some seals and had no signs of energy or heat dissipation, they made another seal and the surgeons noticed the same it was making the whole cycle and no alarms were presented, but there was no seal performance at all, they activated the blade and had some bleedings.The technician at the site restarted the generator and changed the device form port 1 to 2, but the lack of seal continued.So they opened a 2nd device, same lot number and worked well.The surgeon offered to give us a copy of the video.Type of intervention: they opened a 2nd device, same lot number and worked well.Patient status: at the end of the surgery, the patient's health is good not injure occur a cause of the eb010 complaint.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant's experience of insufficient hemostasis could not be replicated or confirmed.The event unit met current specifications.Applied medical is unable to determine the exact root cause of the reported 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: 10529135
• Report Number: 2027111-2020-00557
• Device Sequence Number: 14216962
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)210123(30)01(10)1365170
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 01/23/2021
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1365170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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; INSTRUMENTS AND TROCARS; LENSES; GENERATOR; INSTRUMENTS AND TROCARS; LENSES