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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVOSCI CORP. SURGICAL SUCKER/ SUMP SET; ADULT HEX HANDLE GROOVED - TIP SUCKE
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NOVOSCI CORP. SURGICAL SUCKER/ SUMP SET; ADULT HEX HANDLE GROOVED - TIP SUCKE Back to Search Results
Model Number 201135N
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, an incident was reported to novosci by the distributor medtronic.From their reports, during an operation the tip of a tmp sucker came unattached during use in a surgery.It was uncertain if it was broken while in patients chest.The product was discarded and not available for return.The perfusionist stated that there was no injury to patient due to the incident.
 
Manufacturer Narrative
Device was discarded after surgery.We are waiting on additional info from user.(b)(4).
 
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Brand Name
SURGICAL SUCKER/ SUMP SET
Type of Device
ADULT HEX HANDLE GROOVED - TIP SUCKE
Manufacturer (Section D)
NOVOSCI CORP.
conroe TX
Manufacturer Contact
2021 airport rd
conroe, TX 77301
2812103363
MDR Report Key4392401
MDR Text Key21833235
Report Number1625519-2014-00002
Device Sequence Number1
Product Code DTS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number201135N
Device Lot Number295004/ 294810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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