MAUDE Adverse Event Report: GENICON X-SURGE; ELECTROSURGICAL SCISSOR SHAFT (MONOPOLAR)

Model Number	590-005-010
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is normal shipping procedure to not ship sterile goods in their packaging.However, the x-surge shafts are delicate and a decision to leave them in the trays was made.However, the lids were peeled back to break the sterile barrier to ensure that these were sent as sterile samples.They were then packed into a shelf box and shipped to maintain product integrity.Us customer received the lot with some being samples and some being purchased product.The shelf box was not marked in any manner that would alert us customer that they were non-sterile.Us customer then shipped the shelf box to an end user.To prevent this in the future, all samples are marked with stickers, including the shelf box.Sop-16-7.2-01 rev ad was updated to rev ae in d19062 to include, "all samples shall be marked with a sticker on the packaging; including the shelf box.The sticker shall state whether the sterile or non-sterile".
Event or Problem Description
X-surge nonsterile samples were sent to us customer and accidentally shipped by us customer to an end user for surgery.The end user did not use them in surgery and there was no patient impact.

• Brand Name: X-SURGE
• Common Device Name: ELECTROSURGICAL SCISSOR SHAFT (MONOPOLAR)
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 8830945
• Report Number: 3002590791-2019-00005
• Device Sequence Number: 19185590
• Product Code: GEI
• UDI-Device Identifier: 00877972006695
• UDI-Public: 00877972006695
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: Other
• Device Expiration Date: 02/08/2021
• Device Model Number: 590-005-010
• Device Catalogue Number: 590-005-010
• Device Lot Number: PM17112707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other