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	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic loop colostomy / colostomía en asa por laparoscopia.Event description: "presentation with dr.[name], who was performing a loop colostomy using the voyant maryland ref eb015 lot 1437974 and the voyant electrosurgical generator ref ea010 lot 200000470 when he reported that the clamp was initially indicated to [user facilty] staff that the clamp no longer opened its jaws plus the tissue was sticking too much, a new clamp was provided; however, at the end of the procedure, dr.[name] was approached talking about the incident, he indicated that the sealing cycle was not carried out properly, it ended before and in fact, the sealing tone sounded without pressing the button, which made him suspicious.Use it, which is why i order a new clamp, with which i completed the procedure without any problems.The clamp was collected and is in safekeeping for shipment" additional information was received on 02au22 via email from [name]: "the surgeon was not able to specify if tissue sticking led to bleeding at any point of the surgery, the surgeon did mention tissue sticking could cause bleeding.Also, the surgeon mentions the seal cycle was not completing itself and he heard the seal cycle activated without pressing the seal cycle button.The field team was not in this case, hence is not able to confirm if this was in fact a seal cycle tone, if the seal cycle button was pressed down accidentally" intervention: "order a new clamp, with which i completed the procedure without any problems." patient status: "good.".
Event or Problem Description
Procedure performed: laparoscopic loop colostomy / colostomía en asa por laparoscopia.Event description: "presentation with dr.[name], who was performing a loop colostomy using the voyant maryland ref eb015 lot 1437974 and the voyant electrosurgical generator ref ea010 lot 200000470 when he reported that the clamp was initially indicated to [user facility] staff that the clamp no longer opened its jaws plus the tissue was sticking too much, a new clamp was provided; however, at the end of the procedure, dr.[name] was approached talking about the incident, he indicated that the sealing cycle was not carried out properly, it ended before and in fact, the sealing tone sounded without pressing the button, which made him suspicious.Use it, which is why i order a new clamp, with which i completed the procedure without any problems.The clamp was collected and is in safekeeping for shipment ".Additional information was received on 02aug22 via email from [name]: "the surgeon was not able to specify if tissue sticking led to bleeding at any point of the surgery, the surgeon did mention tissue sticking could cause bleeding.Also, the surgeon mentions the seal cycle was not completing itself and he heard the seal cycle activated without pressing the seal cycle button.The field team was not in this case, hence is not able to confirm if this was in fact a seal cycle tone, if the seal cycle button was pressed down accidentally".Intervention: "order a new clamp, with which i completed the procedure without any problems.".Patient status: "good".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of an unintended rf energy output.Upon closer inspection, an internal fuse switch was observed to be misaligned.Based on the condition of the returned unit and the description of the event, it is likely that the unintentional rf output was caused by the misaligned fuse switch.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15170285
• Report Number: 2027111-2022-00688
• Device Sequence Number: 14707853
• Product Code: GEI
• UDI-Device Identifier: 00607915136956
• UDI-Public: (01)00607915136956(17)230629(30)01(10)1437974
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K193292
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 06/29/2023
• Device Model Number: EB015
• Device Catalogue Number: 101471081
• Device Lot Number: 1437974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• 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: EA010
• Patient Sex: Unknown