MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB015, VOYANT MARYLAND FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB015
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
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: tlh+bso.Mr [name] second time of using the voyant maryland but first time using for the day.Procedure being performed was a tlh + bso.Patient is a (b)(6) year old who has pre cancer condition which is why the procedure is being performed.Patient has diabetes and is taking insulin but no other medication that would affect blood flow or tissue coagulation.[name] assisting mr [name] "wi5" [name] scrubbed and [name] and [name] circulating.A total of 96 activations during the procedure with 4 reactivate alarm codes due to short seal cycles and a total of 6 cleans.On activation number 34 mr [name] commented that he did not think the device was cutting as well as when he last used it and didn't feel as smooth.I suggested that the device was cleaned as he had used it continuously for 34 activations and the device had not yet been cleaned with a small amount of eschar build up.[name] cleaned the device and mr [name] continued to use.After this the device as cleaned more regularly on activation 49,60,69,78,90 and 94.On clean number 78 [name] noticed that the blade lever was sticking when cleaning, she pushed the handle forward to free the blade and wiped the device to get rid of any eschar build up.On activation 94 mr [name] tried to use the voyant to cut a suture he used to suture the vaginal vault so he didn't have to open any laparoscopic scissors.The blade lever jammed and was passed back to scrub nurse [name].On inspection the blade seemed to be sitting half way done the blade channel and when [name] tried to clean the handle was jammed.[name] pushed the handle forward to free the blade and handle.Mr [name] then used the device 2 more times to control small amounts of bleeding around his suture line.When passed back to the scrub nurse at the end of the procedure the blade was still sitting half way up the blade channel.Patient status: no reported injury.Intervention: ni.
Event or Problem Description
Mr [name] second time of using the voyant maryland but first time using for the day.Procedure being performed was a tlh + bso.Patient is a 60 year old who has pre cancer condition which is why the procedure is being performed.Patient has diabetes and is taking insulin but no other medication thst would affect blood flow or tissue coagulation.[name] assisting mr [name] wi5 [name] scrubbed and [name] and [name] circulating.A total of 96 activations during the procedure with 4 reactivate alarm codes due to short seal cycles and a total of 6 cleans.On activation number 34 mr [name] commented that he did not think the device was cutting as well as when he last used it and didnt feel as smooth.I suggested that the device was cleaned as he had used it continuously for 34 activations and the device had not yet been cleaned with a small amount of eschar build up.[name] cleaned the device and mr [name] continued to use.After this the device as cleaned more regularly on activation 49,60,69,78,90 and 94.On clean number 78 [name] noticed that the blade lever was sticking when cleaning, she pushed the handle forward to cfree the blade and wiped the device to get rid of any eschar build up.On activation 94 mr [name] tired to use the voyant to cut a suture he used to suture the vaginal vault so he didnt have to open any laparoscopic scissors.The blade lever jammed and was passed back to scrub nurse [name].On inspection the blade seemed to be sitting half way down the blade channel and when [name] tried to clean the handle was jammed.[name] pushed the handle forward to free the blade and handle.Mr [name] then used the device 2 more times to control small amounts of bleeding around his suture line.When passed back to the scrub nurse at the end of the procedure the blade was still sitting half way up the blade channel.Intervention: mr [name] then used the device 2 more times to control small amounts of bleeding around his suture line.Patient status: no reported injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the blade was exposed.The jaws had dried blood and eschar, which obstructed the blade channel.The unit was disassembled and engineering observed that components of the blade assembly were damaged.Applied medical is unable to determine the root cause of the damage to the components of the blade assembly 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: EB015, VOYANT MARYLAND 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: 8733108
• Report Number: 2027111-2019-00487
• Device Sequence Number: 2572427
• Product Code: GEI
• UDI-Device Identifier: 00607915136956
• UDI-Public: (01)00607915136956(17)200918(30)01(10)1352102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182653
• 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): 08/20/2019

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: 09/18/2020
• Device Model Number: EB015
• Device Catalogue Number: 101471081
• Device Lot Number: 1352102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1