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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED
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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number HAR23
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2018
Event Type  malfunction  
Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed no evidence of clinical use was detected.Tip of teflon pad was detached and not returned.The device was received with the blade pushed up into the external shaft.The contact rings appear to be intact.The torque wrench was not returned with the complaint device.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore, the most likely root causes are: applying improper or inadequate directional and/or rotational force to connect instrument to hand piece.Too much force or torque applied to instrument, or grasping/pulling exceeding torque wrench lifespan (e.G.Usage in multiple cases or devices) ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor) the instructions for use (ifu) state: do not introduce or withdraw the instrument with the jaws open through a trocar sleeve as this may damage the instrument.Avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.Optimum instrument performance is achieved with full trigger closure.An audible and tactile "click" indicates full trigger closure.To achieve full closure of the jaws of the device, squeeze the plastic trigger until you feel it stop against the plastic handle (plastic to plastic).If full trigger closure is released prior to or during activation on tissue, an audible and tactile "click" is evident.Increase grip force until full trigger closure is achieved.Remove the instrument from the package and place it in a sterile work area using aseptic technique.To avoid damage, do not flip the instrument into the sterile field.Inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker if it is not in acceptable condition for the procedure.Take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft.The reported event will continue to be monitored through post-market surveillance.
 
Event Description
It was reported that prior to the procedure while setting up for the case, the tech stated she could not lock the harmonic scalpel (har23) device to the hand piece.The hand piece was cross threaded.It was noted that the tech did not connect the device vertically, as instructed.The physician changed from a laparoscopic procedure to an open procedure, however, this decision was independent of and not based on the device issue.The device was not replaced with another har23 as the device was no longer needed.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
 
Event Description
It was reported that prior to the procedure while setting up for the case, the tech stated she could not lock the harmonic scalpel (har23) device to the hand piece.The hand piece was cross threaded.It was noted that the tech did not connect the device vertically, as instructed.The physician changed from a laparoscopic procedure to an open procedure, however, this decision was independent of and not based on the device issue.The device was not replaced with another har23 as the device was no longer needed.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
 
Manufacturer Narrative
"serial #" was corrected to (b)(4).The lot number is the same and unaffected.The correction does not change the mdr reportability status.
 
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Brand Name
NA
Type of Device
SCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
MDR Report Key7465913
MDR Text Key107193983
Report Number0001056128-2018-00023
Device Sequence Number1
Product Code NLQ
UDI-Device Identifier00885825017330
UDI-Public(01)00885825017330(17)190223(10)8132890
Combination Product (y/n)N
PMA/PMN Number
K133672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/23/2019
Device Model NumberHAR23
Device Catalogue NumberHAR23RR
Device Lot Number8132890
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Date Manufacturer Received05/07/2018
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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