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)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilmed 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.The device history record (dhr) was reviewed and no discrepancies were noted.(b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopic gastric sleeve bypass procedure with a endopath xcel bladeless optiview technology w/stability sleeve and foreign material was present on the obturator tip.The device did contact the patient.However, an alternative device (rpo eth2b5lt) was used to complete the procedure.The intent of the procedure was not altered as a result of the issue and there was no patient consequence.This event has been assessed as reportable.
Additional Manufacturer Narrative
It was reported that a patient underwent a laparoscopic gastric sleeve bypass procedure with a endopath xcel bladeless optiview technology w/stability sleeve and foreign material was present on the obturator tip.The device was examined under magnification for cleanliness, cracks, 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.There are a couple minor scuffs/scratches near the tip that are well within the 2mm acceptability limit, that could possibly be interpreted as debris.But as this is a reprocessed device, such minor surface abrasions are common and the visual criteria accounts for these conditions.Device history record review was completed and no discrepancies were noted.There is no confirmation of any foreign matter on or in the device.Manufacturer's ref.No: pc-(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: 8095711
• Report Number: 2134070-2018-00112
• Device Sequence Number: 16634103
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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 Expiration Date: 05/30/2019
• Device Catalogue Number: ETH2B5LT
• Device Lot Number: 2057644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1