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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COORSTEK MEDICAL RP 360° FLEXIBLE NEEDLE SUTURE PASSER NEEDLE

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COORSTEK MEDICAL RP 360° FLEXIBLE NEEDLE SUTURE PASSER NEEDLE Back to Search Results
Model Number 3910-900-091
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
Device history record review shows no non-conformances associated with the manufacture lot of needles. Review also shows that sample needles from this lot were fatigue tested showing with 95% confidence that 99. 9% of the lot would pass a minimum of 24 cycles. Date product received: the product was not returned for evaluation. Device identification: 3910-900-091/h. Visual inspection: where the product was not returned a visual inspection was not performed. Functional inspection: where the product was not returned a functional inspection was not performed. This is a known failure mode addressed in the risk management file for this product, and does not exceed expected occurrence rates. Occurrence rates are monitored for trends. Service history review: there has been no service on this device. Manufacturing date: 12-21-2015. Root cause(s): where the device was not returned and the description of the complaint does not contain enough information, a root cause could not be determined. Manufacturer error: there is nothing in the description of the complaint and there was nothing found in the review of the device history record that would indicate this is a result of a manufacturing error. Country of event: usa.
 
Event Description
Rp 360 needle tip broke when being used with the champion suture passer.
 
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Brand NameRP 360° FLEXIBLE NEEDLE
Type of DeviceSUTURE PASSER NEEDLE
Manufacturer (Section D)
COORSTEK MEDICAL
867 west 400 north
logan UT 84321
Manufacturer (Section G)
COORSTEK MEDICAL
867 west 400 north
logan UT 84321
Manufacturer Contact
robert bates
867 west 400 north
logan, UT 84321
4357741500
MDR Report Key7080920
MDR Text Key94409819
Report Number3004086872-2017-00012
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/21/2017
Device Model Number3910-900-091
Device Lot Number1001972
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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