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

Model Number MIC1332

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

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 a stray wire was noted on the device.The device was used to retrieve two or three biopsies.When the next biopsy was to be obtained, it was noticed that it ¿didn¿t feel right¿ when the biopsy was opened.The device was removed and examined, when the stray wire was noted.The patient did not have any issues after the procedure, and was reported that no part of the device was left in the patient.

• 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 parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 6537491
• MDR Text Key: 74231192
• Report Number: 2134070-2017-00009
• 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
• Report Date: 04/04/2017

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: 12/01/2017
• Device Model Number: MIC1332
• Device Catalogue Number: MIC1332
• Device Lot Number: 1979925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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