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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
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STRYKER-ENDOSCOPY LAKELAND 5300; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R Back to Search Results
Model Number LF1937
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Event Description
It was reported the device arrived visibly broken at the jaws with damage to the packaging.The complaint device was replaced and the procedure was reported to have been completed successfully.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported the device arrived visibly broken at the jaws with damage to the packaging.The complaint device was replaced and the procedure was reported to have been completed successfully.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
 
Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The chipboard box was damages on the outside.Wrinkles and creases where seen on the corner and sides of the box.The packaging tray was damage on the corner.There was a crack exposing the device compromising the hermetic seal.The devices was damage at the tip.The jaw was bent and the grey plastic cover was separating form the jaw.The results of the investigation determined that the reported event was confirmed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause was shipping/handling/storage damage subsequent to distribution from stryker.The instructions for use (ifu) state: inspect packaging before opening.The contents of the package are sterile if the package has not been compromised.Do not use the instrument if the sterility has been compromised.If the package is damaged or if it was opened and the instrument not used, return the instrument and the package to stryker.The contents of the package are provided sterile by method of ethylene oxide gas and is for single patient use only.Do not use if there is any evidence of damage to the package.The reported event will continue to be monitored through post-market surveillance.
 
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Brand Name
NA
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
Manufacturer (Section D)
STRYKER-ENDOSCOPY LAKELAND 5300
5300 region ct
lakeland FL 33815
Manufacturer (Section G)
STRYKER-ENDOSCOPY LAKELAND 5300
5300 region ct
lakeland FL 33815
Manufacturer Contact
andy dobos
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key19028124
MDR Text Key339229237
Report Number0001056128-2024-00035
Device Sequence Number1
Product Code NUJ
UDI-Device Identifier07613327504897
UDI-Public07613327504897
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLF1937
Device Catalogue NumberLF1937RR
Device Lot Number15309163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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