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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE RENEWAL 72203013 @PLATINUM, INCISORPLS BLADE

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MEDLINE INDUSTRIES INC. MEDLINE RENEWAL 72203013 @PLATINUM, INCISORPLS BLADE Back to Search Results
Model Number REP112994
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/23/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that a device got stuck in the patient's knee mid surgery and required removal. A new blade was opened to finish the procedure. The patient was reportedly undergoing a left knee scope and during the procedure the blade broke requiring the surgeon to manually remove the blade by hand. The surgeon opened another shaver and completed the procedure without further incident. No serious injury or follow up medical care was reported related to the customer reported issue. No additional medication was required as a result of the reported incident. There was no report of any adverse patient consequence, no effect on the patient's stability, and no medical intervention required as a result of the incident. No additional information is available. Due to the reported issue and in an abundance of caution this is an mdr reportable event. The actual sample was returned to for evaluation however a root cause could not be determined. If additional information becomes available this report will be reopened and reevaluated.
 
Event Description
It was reported that a device got stuck in the patient's knee mid surgery and required removal. A new blade was opened to finish the procedure without further incident.
 
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Brand NameMEDLINE RENEWAL
Type of Device72203013 @PLATINUM, INCISORPLS BLADE
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield, il
Manufacturer Contact
karen trutsch
three lakes drive
northfield, il 
MDR Report Key10421267
MDR Text Key203359686
Report Number3032391-2020-00005
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREP112994
Device Catalogue Number72203013RH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/18/2020 Patient Sequence Number: 1
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