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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SINAPI BIOMEDICAL (PTY) LTD MAXIMA DISPOSABLE SAFETY SCALPEL
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SINAPI BIOMEDICAL (PTY) LTD MAXIMA DISPOSABLE SAFETY SCALPEL Back to Search Results
Catalog Number 570-0246
Device Problems Mechanical Problem (1384); Use of Device Problem (1670)
Patient Problem No Patient Involvement (2645)
Event Date 09/18/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer tested both the frontal lock, home position and final lock positions of henry schein batch 17030710, manufactured on 06/ 03/ 2017.All scalpels performed as designed and we could not dislodge the blade out of the final lock position.The manufacturer also tested 20 samples from retention stock of batch manufactured before the batch in question (hs till batch 17030709) and 20 retention samples from stock manufactured after the batch in question (ms23ns batch 17031719) and could not find any failures of frontal lock, homing position or final lock.The manufacturer also checked the batch records for any problems which may have been alerted during manufacturing of this batch but could not find any problems.The manufacturer cannot exclude the possibility that the user did not engage the final lock.The blade holder can only be dislodged from the final lock position using excessive force.We advise that henry schein please retrain end users and also stress that scalpel must be treated as sharp until disposed.The safety scalpel is manufactured using a translucent handle which ensures the blade is always visible.We further suggest that a warning note is added to warn users to always treat as a "sharp" object and all times confirm and visually check the position of the blade on the device when using a safety scalpel or any safety device.
 
Event Description
It was reported that the blade was used during a debridement procedure.Safety retractable was closed but re-opened when put into sharps container.Rn was stabbed in the finger.Blade did not stay retracted under safety piece on the blade.Rn was sent to er for infection control.Patient was also sent to the lab for blood work.No harm to the patient was reported.
 
Manufacturer Narrative
The manufacturer tested both the frontal lock, home position and final lock positions of (b)(6) batch: 17030710, manufactured on 06/ 03/ 2017.All scalpels performed as designed and we could not dislodge the blade out of the final lock position.The manufacturer also tested 20 samples from retention stock of batch manufactured before the batch in question (hs till batch: 17030709) and 20 retention samples from stock manufactured after the batch in question (ms23ns batch: 17031719) and could not find any failures of frontal lock, homing position or final lock.The manufacturer also checked the batch records for any problems which may have been alerted during manufacturing of this batch but could not find any problems.The manufacturer cannot exclude the possibility that the user did not engage the final lock.The blade holder can only be dislodged from the final lock position using excessive force.We advise that (b)(6) please retrain end users and also stress that scalpel must be treated as sharp until disposed.The safety scalpel is manufactured using a translucent handle which ensures the blade is always visible.We further suggest that a warning note is added to warn users to always treat as a "sharp" object and all times confirm and visually check the position of the blade on the device when using a safety scalpel or any safety device.Update: 10/30/2019 : additional information.The end-user customer was unable to return the suspect device to the manufacturer for investigation.The manufacturer has concluded their investigation, the customer has been notified of the result.We consider this file closed.
 
Event Description
It was reported that the blade was used during a debridement procedure.Safety retractable was closed but re-opened when put into sharps container.Rn was stabbed in the finger.Blade did not stay retracted under safety piece on the blade.Rn was sent to er for infection control.Patient was also sent to the lab for blood work.No harm to the patient was reported.
 
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Brand Name
MAXIMA DISPOSABLE SAFETY SCALPEL
Type of Device
SAFETY SCALPEL
Manufacturer (Section D)
SINAPI BIOMEDICAL (PTY) LTD
arc-infruitec north campus
lelie road
stellenbosch, 7600
SF  7600
MDR Report Key9132147
MDR Text Key197944179
Report Number1058382-2019-00005
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/06/2022
Device Catalogue Number570-0246
Device Lot Number1703710
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2019
Distributor Facility Aware Date09/20/2019
Device Age30 MO
Event Location Hospital
Date Report to Manufacturer09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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