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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LIGASURE BLUNT TIP LAPAROSCOPIC SEALER; LAPAROSCOPIC ACCESSORY
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STRYKER SUSTAINABILITY SOLUTIONS LIGASURE BLUNT TIP LAPAROSCOPIC SEALER; LAPAROSCOPIC ACCESSORY Back to Search Results
Catalog Number LF1637
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2016
Event Type  malfunction  
Event Description
During lavh (laparoscopic assisted vaginal hysterectomy), 5mm blunt tipped laparoscopic ligasure stopped cutting per surgeons.Instrument removed from field and replaced with another.No harm to patient manufacturer response for handpiece, ligasure blunt tip laparoscopic sealer (per site reporter): manufacturer's rep took device for evaluation.Patient was not harmed or affected therefore hospital did not retain device.
 
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Brand Name
LIGASURE BLUNT TIP LAPAROSCOPIC SEALER
Type of Device
LAPAROSCOPIC ACCESSORY
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS
5300 region court
lakeland FL 33815
MDR Report Key5719693
MDR Text Key47199536
Report Number5719693
Device Sequence Number1
Product Code NWV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/09/2016
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 Physician
Device Expiration Date02/28/2019
Device Catalogue NumberLF1637
Device Lot Number4398454
Other Device ID Number5MM X 37 CM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/09/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/13/2016
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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