MAUDE Adverse Event Report: STERILMED, INC.; FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED

Model Number MIC1332

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was reviewed and no discrepancies were found.

Event Description

It was reported that following a procedure, during cleaning with tap water and a gauze, black residue was noticed on the device.There has been no patient harm or consequence reported.Follow up has been requested should any further patient information come available.

Manufacturer Narrative

The device was returned in good visual condition.During evaluation, the entire length of the device shaft was wiped down with tap water and produced light black residue marks on the cloth as reported by the user facility.A second wipe down with 70% isopropyl alcohol was then performed.It was discovered that while performing the second wipe down over the black lines on the shaft, the transfer of black residue on the cloth was heavier.There was no transfer of black residue observed on the cloth when wiping down the orange section of the shaft.In order to determine root cause, fifteen unused, reprocessed devices of the same model were then evaluated.Findings from this evaluation showed the same black residue coming off the black lines and transferring onto the cloth.The devices are manufactured with a black ink on the sheath.The black residue was identified as a transfer of black ink that is used in original device production by the original equipment manufacturer (oem).An evaluation was also performed on a new non-reprocessed oem device and the same findings were observed indicating that the cause of the issue is not associated with reprocessing.There have been no other reported complaints for this issue from other facilities.The device history record was reviewed and no discrepancies were noted.

• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 5010 cheshire parway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5721352
• MDR Text Key: 47288515
• Report Number: 2134070-2016-00041
• Device Sequence Number: 1
• Product Code: NON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2017
• Device Model Number: MIC1332
• Device Catalogue Number: MIC1332
• Device Lot Number: 1932294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1