DISSECTING KITTNER 40CM CD801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-25 for DISSECTING KITTNER 40CM CD801 manufactured by Conmed Corporation.

Event Text Entries

[187567649] The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10


[187567650] The conmed representative reported on behalf of their facility that the cd801, laparoscopic kittner, became detached from the probe during a laparoscopic hysterectomy on (b)(6) 2020. The detached sponge tip was retrieved using graspers. There was only minutes described as the delay. There was no patient injury or impact. This report is being raised based on device malfunction with the potential of injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1320894-2020-00123
MDR Report Key9878456
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-05
Date Mfgr Received2020-03-10
Device Manufacturer Date2020-01-27
Date Added to Maude2020-03-25
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 FDA3
Event Location3
Manufacturer ContactMELANIE LANNON
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO, FL
Manufacturer CountryUS
Manufacturer Phone3995209
Manufacturer G1CONMED CORPORATION
Manufacturer Street525 FRENCH ROAD
Manufacturer CityUTICA, NY
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISSECTING KITTNER 40CM
Generic NameLAPAROSCOPIC BLUNT DISSECTOR
Product CodeGCJ
Date Received2020-03-25
Catalog NumberCD801
Lot Number202001271
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORPORATION
Manufacturer Address525 FRENCH ROAD UTICA, NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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