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 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 the jaws were broken when trying to biopsy tissue from the patient.No patient harm or consequences was reported.Additional information was requested, but there was no additional information available.

Manufacturer Narrative

The biopsy forceps was returned to the manufacturer with its jaws damaged but functional.A portion of the opening and closing mechanism is out of position and clearly sticks out from the jaws.The damage is obvious to the naked eye and the device would not be shipped in this condition.According to the account, the device became damaged when it was used in the field.The root cause for the damage remains unknown, though the device may have been damaged during its handling or use in the field.

• 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: 5875363
• MDR Text Key: 52095741
• Report Number: 2134070-2016-00056
• 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: 09/05/2016

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: 04/18/2017
• Device Model Number: MIC1332
• Device Catalogue Number: MIC1332
• Device Lot Number: 1941169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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