MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB040, VOYANT OPEN FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB040
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
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: right hemicolectomy.Incident description: doc.[name] (head of general and bariatric surgery) did the procedure of right hemicolectomy.He knows voyant very well.Doctor used voyant open fusion and during the procedure when he closed the jaws, he couldn't open it any more.Even after procedure and after they washed device, they couldn't open the jaw.Additional information received from distributor via email on 29jan2020: the device jammed without tissue between the jaws.The situation was resolved by using another device.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit and the jaws of the device were able to be opened.As a result, the complainant's experience of jaws locking could not be confirmed or replicated.Engineering observed that the event unit had dried blood and eschar on the jaws of the device and within the blade channel.Based on the condition of the returned unit and testing that was performed, it is likely that the reported event was caused by the excessive blood and eschar that had built up within the blade channel.The event was determined to be reportable based on the original description of the event.However, upon evaluation of the event unit, the event is deemed not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: right hemicolectomy.Incident description: doc.[name] (head of general and bariatric surgery) did the procedure of right hemicolectomy.He knows voyant very well.Doctor used voyant open fusion and during the procedure when he closed the jaws, he could't open it any more.Even after procedure and after they washed device, they could't open the jaw.Additional information received from distributor via email on 29jan2020: the device jammed without tissue between the jaws.The situation was resolved by using another device.Patient status: no patient injury.

• Brand Name: EB040, VOYANT OPEN FUSION, 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: 9729654
• Report Number: 2027111-2020-00368
• Device Sequence Number: 2928201
• Product Code: GEI
• UDI-Device Identifier: 00607915137953
• UDI-Public: (01)00607915137953(17)210620(30)01(10)1356266
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K180699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 06/20/2021
• Device Model Number: EB040
• Device Catalogue Number: 101223401
• Device Lot Number: 1356266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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: ELECTROSURGICAL GENERATOR