MAUDE Adverse Event Report: STERILMED, INC. ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Catalog Number	ETH2B5LT
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Date of event: the event date is unknown.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopic procedure with a endopath xcel bladeless optiview technology w/stability sleeve and the physician noted tissue debris inside the device.The device did contact the patient.There was no patient consequence.This event has been assessed as reportable.
Additional Manufacturer Narrative
It was reported that a patient underwent a laproscopic procedure with a endopath xcel bladeless optiview technology w/stability sleeve and the physician noted tissue debris inside the device.The device was returned loose inside a zipper-sealed plastic bag, removed from its original packaging.The tray form was not returned but the shipment included the tyvek lid with a label attached.A review of the device history record (dhr), identified by the lot number on the label, found the device passed all visual criteria, both pre and post-sterilization, prior to being shipped to the customer.No discrepancies are observed upon review of the dhr.Though the device had been removed from its sterile packaging and it was unclear what environment it had been handled within, it was examined under magnification for cleanliness, discoloration, nicks, etc.There was no observed foreign matter either attached or loose to the exterior or interior of the obturator's tip or any other part of the obturator.The distal tip appears in good visual condition.There is no confirmation of any foreign matter on or in the device.Manufacturers ref.No.: (b)(4).

• Brand Name: ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8207018
• Report Number: 2134070-2018-00117
• Device Sequence Number: 16661348
• Product Code: NLM
• UDI-Device Identifier: 10888551010795
• UDI-Public: 10888551010795
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K043592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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 Catalogue Number: ETH2B5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1