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 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a laparoscopy procedure with a endopath xcel blade-less optiview technology w/stability sleeve and the physician reported debris in obturator while using reprocessed trocar.The device did contact the patient.However, there was no patient consequence.This event has been assessed as reportable.

• 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
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: gabriel alfageme ; 5010 cheshire parkway; ste 2; plymouth, MN 55446 ; 9497898687
• MDR Report Key: 8190394
• MDR Text Key: 131384601
• Report Number: 2134070-2018-00116
• Device Sequence Number: 1
• Product Code: NLM
• UDI-Device Identifier: 10888551010795
• UDI-Public: 10888551010795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ETH2B5LT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1