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Model Number SB4040RC
Device Problems Complete Blockage (1094); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/28/2017
Event Type  malfunction  
Manufacturer Narrative
- reconfirmation of complaint failure: our inspection could not find any external damages or cracks on the blades. -other defect that has been found during investigation: no other findings. -whether the device meet specifications?: it was reported that a piece of device fell off, but it doesn't affect its functionality. Thus the device conforms to the specification. -other investigation result. Sb4040rc is assumed to be the subject device that was actually used during the event, based on the picture provided by the user facility and user's comments. The debris(metal fragment) was not returned to omsc. We could estimate the size of debris about 2mm based on the picture. The relationship of the device to the reported incident or adverse event. (in case of pae): a debris came out from the subject device fell into patient. The pae is associated with the subject device. Conclusion summary: there is no significant external damage or crack on the distal end of the device( both the inner blade and the outer blade. ) we suspect that the debris spouted out from the distal end of device is a part of nickel plating on the inner blade. The inner blade seems to have no damage of plating as long as we observed from outside. It may have plating damage inside. The device will be sent to osta for deeper investigation to determine the exact root cause. Comments to customer or originator/sales-bc: when a clog is encountered, please withdraw the blade from nasal cavity before starting declog feature to remove the clog. Please explain your customer to follow the caution note below that is described in the instruction for use. "to avoid splashing of potentially hazardous biomaterial, always ensure that the blade tip is fully submerged in sterile water or sterile saline before squeezing the declog pressure bulb. Water or saline in the dish must be deep enough to fully submerge the blade tip and cover the blade window. ".
Event Description
The subject blade (sb4040rc)combined with a handpiece (mdhp100a) was used during a tumorectomy by endoscopic sinus surgery. During the first half of the procedure, a burr combined with a handpiece was stopped working. The procedure was continued with reserve handpiece (mdhp100a), burr (bur4015dt), tube set (ts101dc). After completion of the treatment with the burr, the procedure was continued with replaced subject blade (sb4040rc). Tissue was clogged in the blade during the procedure. When the de-clog air bulb was pushed to de-clog the blade, foreign debris estimated to be metal fragments or plating pieces were spouted out from the tip of blade and fallen inside patient¿s body. After retrieving the foreign debris with an uncertain suction tube owned by the hospital, the procedure was completed using a reserve blade (sb4040rc). There is no patient¿s injury reported. The retrieved foreign debris was not returned. This complaint (b)(4) is regarding the blade (sb4040rc) involved with foreign debris falling inside patient¿s body. Another complaint (b)(4) is regarding the first handpiece combined with the burr which was stopped working.
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Manufacturer (Section D)
136 turnpike road
southborough MA 01772
Manufacturer Contact
terrence sullivan
136 turnpike road
southborough, MA 01772
MDR Report Key6518420
MDR Text Key73742693
Report Number1037007-2017-00004
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberSB4040RC
Device Lot NumberJC931951
Other Device ID NumberUDI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial