KITTNER DISSECTOR 28-0801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-11-23 for KITTNER DISSECTOR 28-0801 manufactured by Medsorb Dominicana, S.a..

Event Text Entries

[60763309] Root cause: the raw material is supplied to deroyal industries, inc. By (b)(4). Therefore, a supplier corrective action request (scar) was issued to the (b)(4). In its response, (b)(4) stated its investigation determined some glue operators used a slightly varied method of wrapping tape on the end of the stick. This variation left the potential for glue to be in the incorrect area of the tape. Additionally, a gap was identified in the training of operators who had been in the position for less than 1 year. Corrective action: in the scar, (b)(4) has identified the following corrective actions: add more details to the manufacturing procedure (manufacturing of endokittner (b)(4)) to clarify the steps of the gluing process; retrain all operators on proper tip folding, gluing, and wrapping techniques; and supervisor will follow-up to ensure all operators are trained on the manufacturing procedure and related quality documentation. Corrections: in the scar, (b)(4) has stated personnel involved were notified through written notification about the non-conformity; inventory verification at the (b)(4) warehouse was performed and lots 4k303 and 16h3290 will be reinspected at 100%; deroyal will return lots 16f2326, 16h3290, 16d1367, and 16b0344 to (b)(4) for reinspection at 100%. Investigation summary: an internal complaint ((b)(4)) was received indicating that the sponge tip of a kittner dissector ((b)(4)) had fallen into a patient during a procedure. A lot number was not reported. The potential lot numbers were reviewed and no discrepancies that may have contributed to the reported issue were identified. (b)(4) is used within finished (b)(4). The raw material is supplied by (b)(4). The 2014-2016 scar and supplier notification letter (snl) logs were reviewed for similar complaints. Similar complaints were identified in 2016. A scar was issued to (b)(4) and a response was received november 21, 2016. As a result of the vendor investigation, deroyal has placed the product under purchase inspection and assigned verification of the complaint. Preventive action: in the scar, (b)(4) has stated the area supervisor will be monitoring each operator to ensure the gluing process is performed correctly. The production inspector will continue to check all sticks for tip retention. The investigation is complete. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[60763310] Sponge at the tip fell into patient during a procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320762-2016-00023
MDR Report Key6124009
Report SourceDISTRIBUTOR,USER FACILITY
Date Received2016-11-23
Date of Report2016-10-26
Date of Event2016-10-21
Date Mfgr Received2016-10-26
Date Added to Maude2016-11-23
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 ContactELIZABETH REED
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653621256
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street1595 HIGHWAY 33 SOUTH
Manufacturer CityNEW TAZEWELL TN 37825
Manufacturer CountryUS
Manufacturer Postal Code37825
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKITTNER DISSECTOR
Generic NameDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDI
Date Received2016-11-23
Model Number28-0801
Lot NumberNOT PROVIDED
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDSORB DOMINICANA, S.A.
Manufacturer AddressZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS SAN PEDRO DE MACORIS, DR


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-23

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