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

Catalog Number ETH2B5LT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

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 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.

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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8095711
• MDR Text Key: 128409382
• Report Number: 2134070-2018-00112
• Device Sequence Number: 1
• Product Code: NLM
• UDI-Device Identifier: 10888551010795
• UDI-Public: 10888551010795
• Combination Product (y/n): N
• PMA/PMN Number: K043592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1