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 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

The account's reported complaint of black residue on the device has been confirmed in previous complaints, however,microvasive biopsy forceps are manufactured with a black ink on its sheath and what the account is referring to as black residue is actually a transfer of the black ink the oem uses during production of the device.There have been no other reported complaints for this issue from other accounts.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 to the manufacturer for evaluation.The wipe down of the device with alcohol reveals that the only portions where there is a black residue is where the device has been inked by the manufacturer with black stripes.This is an oem issue, directly related to the manufacture of the device.A complaint query reveals that this is the only account with the black residue complaint.As this is an oem issue, no corrective action has been issued at this time.The black residue has also been confirmed when the same wipe down was performed on an unopened oem product.

• 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: 5819034
• MDR Text Key: 50326548
• Report Number: 2134070-2016-00052
• 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: 06/29/2016

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: 03/22/2017
• Device Model Number: MIC1332
• Device Catalogue Number: MIC1332
• Device Lot Number: 1936151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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