SPIDER FLEXIBLE CLIP APPLIER 9000029

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-11-08 for SPIDER FLEXIBLE CLIP APPLIER 9000029 manufactured by Transenterix, Inc..

Event Text Entries

[20230347] During an abdominal laparoscopic cholecystectomy procedure the surgical sales rep indicated that the clip applier had difficulty closing clips. The clip applier was removed from the procedure and a new applier was used. The replacement worked appropriately.
Patient Sequence No: 1, Text Type: D, B5


[20599997] Upon investigation of complaints related to clip applier functionality, a non-safety related quality issue was identified. The decision was made to recall the clip applier product and a recall was executed on (b)(4) 2012. Fda was notified on (b)(4) 2012. (b)(4). During the recall closure and in discussions with fda on (b)(4) 2012, it was determined that mdrs should be filed to ensure complete documentation. This mdr is being filed retrospectively.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007593944-2012-00014
MDR Report Key2844245
Report Source05
Date Received2012-11-08
Date of Report2012-06-19
Date of Event2012-06-19
Date Mfgr Received2012-06-19
Device Manufacturer Date2012-03-01
Date Added to Maude2013-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. TAMMY CARREA, VP
Manufacturer Street635 DAVIS DRIVE SUITE 300
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9197658420
Manufacturer Street2933 S. MIAMI SUITE 119
Manufacturer CityDURHAM NC 27703
Manufacturer CountryUS
Manufacturer Postal Code27703
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-2137-2012
Event Type3
Type of Report3

Device Details

Brand NameSPIDER FLEXIBLE CLIP APPLIER
Generic NameLAPAROSCOPIC, GENERAL AND PLASTIC SURGERY
Product CodeOTJ
Date Received2012-11-08
Returned To Mfg2012-06-22
Model Number9000029
Catalog Number9000029
Lot NumberDC082122
ID NumberNA
Device Expiration Date2014-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTRANSENTERIX, INC.
Manufacturer AddressDURHAM NC


Patients

Patient NumberTreatmentOutcomeDate
10 2012-11-08

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