OPERATING SCS 6-1/2 STR B/B 100138

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-26 for OPERATING SCS 6-1/2 STR B/B 100138 manufactured by Integra York, Pa Inc..

Event Text Entries

[129354249] The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report numbers: 2523190-2018-00145; 2523190-2018-00146; 2523190-2018-00147; 2523190-2018-00148; 2523190-2018-00149; 2523190-2018-00150; 2523190-2018-00151; 2523190-2018-00152; 2523190-2018-00153; 2523190-2018-00162; 2523190-2018-00154; 2523190-2018-00155; 2523190-2018-00156; 2523190-2018-00157; 2523190-2018-00163; 2523190-2018-00158; 2523190-2018-00159; 2523190-2018-00160; 2523190-2018-00161; 2523190-2018-00164; 2523190-2018-00166; 2523190-2018-00167.
Patient Sequence No: 1, Text Type: N, H10


[129354250] This is 21 of 23 reports. It was reported by a customer that a 100138 ochsner operating scissor failed quality control with a suspected bioburden, causing an operating room delay on (b)(6) 2018, for an unspecified procedure. Additional information was received on 06-nov-2018, stating that the sterility of the device was compromised, it was tested for proteins and removed from the field. The surgical case was broken down. The device was not in contact with the patient. No reports of patient injury or death alleged.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2018-00165
MDR Report Key8103490
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-11-26
Date of Report2018-11-06
Date of Event2018-08-16
Date Mfgr Received2018-11-27
Date Added to Maude2018-11-26
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 ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPERATING SCS 6-1/2 STR B/B
Generic NameN/A
Product CodeLRW
Date Received2018-11-26
Returned To Mfg2018-11-13
Catalog Number100138
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-26

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