MAUDE Adverse Event Report: ECOLAB MICROTEK GENERAL PURPOE PROBE COVER

Model Number PC1419

Device Problem Device Issue (2379)

Patient Problems Breast Mass (2439); Patient Problem/Medical Problem (2688)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed at the manufacturing site in the (b)(4).Based on the dhr reviewed, this lot had (b)(4) pieces and it was manufactured on 7/16/2015.No defects were reported during processing, packaging or final inspection.The investigation revealed that this problem was not due to an assembly, material, or process issues.No defective product has been returned to manufacturer for evaluation.Since no device was returned for analysis the root cause for the event has not been determined.

Event Description

On (b)(6) 2015- end user (physician) has reported medwatch (b)(4) to the fda and stated that during the procedure for the right breast lumpectomy, the end user found contamination (blood) inside the probe cover during the procedure.End user checked very carefully and found a small hole at the seam of cover.A small hole could have been present prior to use or could been a weak spot that opened with use.On the same day that the end user reported this to medwatch, there were complaints of two instances of gross contamination from the neoprobe handle and possibly effected sterility.There was no patient injury report of additional treatment.Product number pc1419, lot number reported was d151951.

• Brand Name: GENERAL PURPOE PROBE COVER
• Type of Device: PROBE COVER
• Manufacturer (Section D): ECOLAB MICROTEK; 370 wabasha street north; st. paul MN 55102
• MDR Report Key: 5158595
• MDR Text Key: 28561291
• Report Number: 8043817-2015-00005
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/14/2020
• Device Model Number: PC1419
• Device Lot Number: D151951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 MO
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1