MAUDE Adverse Event Report: STERILMED, INC.

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that there had been metal shavings while doing scopes.Additional information received reported that the shavings were noticed during knee arthroscopies "pretty soon" after starting the procedure.The device was not replaced and all of the shavings were removed.There were no usual sound or loading issues using the devices.There were no injuries to the patients.See related mfr report #2134070-2014-00198.

Manufacturer Narrative

No device was returned to the manufacturer as of the date of this report.A supplemental report will be sent if a device is received.

• Brand Name: NA
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: patricia kaufman ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4345144
• MDR Text Key: 15126664
• Report Number: 2134070-2014-00199
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1