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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. TROCAR-REPROCESSED XCEL BLUNT TIP; LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED
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STRYKER SUSTAINABILITY SOLUTIONS, INC. TROCAR-REPROCESSED XCEL BLUNT TIP; LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED Back to Search Results
Catalog Number H12LP
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 05/14/2018
Event Type  malfunction  
Event Description
During a lap chole procedure.Specimen obtained by surgeon with trocar.Upon closing incision site, noticed the suture anchor had broken off the reprocessed trocar.
 
Event Description
During a lap chole procedure.Specimen obtained by surgeon with trocar.Upon closing incision site, noticed the suture anchor had broken off the reprocessed trocar.
 
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Brand Name
TROCAR-REPROCESSED XCEL BLUNT TIP
Type of Device
LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS, INC.
5300 region ct
lakeland FL 33815
MDR Report Key7768602
MDR Text Key116620820
Report Number7768602
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/17/2018
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 No Information
Device Catalogue NumberH12LP
Device Lot Number7572509
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2018
Date Report to Manufacturer08/09/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/09/2018
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/09/2018
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age20075 DA
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