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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURG, CUTTING/COAGULATION ACC, LAPAROSCOPIC/ENDOSCOPIC, REPROCESS
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STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURG, CUTTING/COAGULATION ACC, LAPAROSCOPIC/ENDOSCOPIC, REPROCESS Back to Search Results
Model Number HAR36R
Device Problems Melted (1385); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
 
Event Description
It was reported that a patient underwent a laparoscopy procedure with a reprocessed harmonic scalpels/shears and a plastic piece on the blade melted off the device and then adhered to the ovary.Surgeon was able to remove the piece successfully.The device passed pre-test and was working normally prior to the issue.The generator did not show any error messages.The device was changed to an alternative device and the procedure was completed without patient consequence.It was noted that the intent of the procedure was altered, however exact details on how it was altered has not yet been received.
 
Manufacturer Narrative
It was reported that a patient underwent a laparoscopy procedure with a reprocessed harmonic scalpels/shears and a plastic piece on the blade melted off the device and then adhered to the ovary.Surgeon was able to remove the piece successfully.The device was returned for investigation and it was observed that the tissue pad was melted, and the account returned the fragment stuck to a piece of adhesive tape.Per the failure modes and effects analysis (fmea), this melting was likely due to "activation of device without tissue between the blade and the pad." the presence of melting on the pad, as well as observed contaminants on parts of the jaw, is indicative that the device was still actuated within the operative field after sealing had been completed.Continuing to actuate and operate the device in this manner, could adversely melt the tissue pad and affect the functionality of the device.The device was attached to the gen11 generator.The device was identified, and the system display showed that it was ready for device usage.As the pad was melted and there was a returned tissue pad fragment, the reported issue is confirmed.However, as the device was being handled at the time of the observed failure, no conclusion as to the cause for the reported issue is determined.The fmea lists operator error, activation of device without tissue between blade and pad as possible causes.The device history record for lot 2035488 was reviewed and there were no observed discrepancies.The device passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted and there were no identified nonconformances.E1.Initial reporter phone number added.Manufacturer's ref.No: (b)(4).
 
Manufacturer Narrative
The product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
 
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Brand Name
HARMONIC SCALPELS/SHEARS
Type of Device
ELECTROSURG, CUTTING/COAGULATION ACC, LAPAROSCOPIC/ENDOSCOPIC, REPROCESS
Manufacturer (Section D)
STERILMED, INC.
5010 cheshire parkway
ste 2
plymouth MN 55446
MDR Report Key9829772
MDR Text Key191837064
Report Number2134070-2020-00003
Device Sequence Number1
Product Code NUJ
UDI-Device Identifier10888551045117
UDI-Public10888551045117
Combination Product (y/n)N
PMA/PMN Number
K161086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/17/2021
Device Model NumberHAR36R
Device Catalogue NumberHAR36R
Device Lot Number2035488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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