MAUDE Adverse Event Report: ECOLAB MICROTEK MEDICAL ECOLAB/SKYTRON; DISPOSABLE LIGHT HANDLE COVER

Model Number 20991

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

One distributor: (b)(4) has reported a complaint to ecolab-microtek medical about the incident appeared on (b)(6) 2014.The report stated as "two light handle covers fell into the sterile field while a patient was present".There were no patient injury and treatment reported of the incident.

Manufacturer Narrative

Investigations of this incident will be conducted by ecolab-microtek.Ecolab-microtek has not received a defective product from the distributor for review/evaluation as yet.This report is an initial report for 30 days.Ecolab-microtek will submit any follow-up report with one month of the day the information is received as the root cause determination and investigation of the incidents continues.

Manufacturer Narrative

Investigations of this incident will be conducted by ecolab-microtek.Ecolab-microtek has not received a defective product from the distributor for review/evaluation as yet.This report is an initial report for 30 days.Ecolab-microtek will submit any follow-up report with one month of the day the information is received as the root cause determination and investigation of the incidents continues.Follow-up reports 9/15/2015: the dhr was reviewed and it was noted that lot number c14316, and 20 each, did not indicated any nonconformities.Part number 20991, lot number 140526f, five pieces have been tested by lab technician and the results were evaluated and the diameter measured is with in specification.It can only be speculated that the end user did not engage the cover to secure on the handle locking pins or the locking pins did not function properly.The investigation is inconclusive due to lack of lot numbers, this based on the condition or age of the handle used in the procedure.Note: no complaints have been reported relating to the equivalent product model #20991 (handle cover) which is distributed in the united stated.

Event Description

One distributor: (b)(4) has reported a complaint to ecolab-microtek medical about the incident happened on (b)(6) 2014.The report stated as "two light handle covers fell into the sterile field while a patient was present".There were no patient injury and treatment reported of the incident.

• Brand Name: ECOLAB/SKYTRON
• Type of Device: DISPOSABLE LIGHT HANDLE COVER
• Manufacturer (Section D): ECOLAB MICROTEK MEDICAL; microtek dominicana, s.a.; la romana, dominican republic
• Manufacturer Contact: pichsoth kim ; 307 wabasha street north; st. paul, MN 55102 ; 6512502886
• MDR Report Key: 4959972
• MDR Text Key: 6041103
• Report Number: 8043817-2015-00002
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• PMA/PMN Number: K901154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial
• Report Date: 06/26/2015,07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20991
• Device Catalogue Number: 20991
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2015
• Distributor Facility Aware Date: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1