|
Catalog Number 101261 |
Device Problems
Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/16/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
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, 2523190-2018-00148, 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, 2523190-2018-00165, 2523190-2018-00166, 2523190-2018-00167.
|
|
Event Description
|
This is 3 of 23 reports.It was reported by a customer that a 101261 carb-edge metz scs 7 cvd del 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 (b)(6) 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.
|
|
Manufacturer Narrative
|
Additional information was received on 27nov2018: an integra site meeting with the customer identified that there was no bioburden as initially reported, however, the issue was rust and corrosion.The jarit instruments were manually washed, put through an ultrasonic bath, and then placed in an autowash with steris prolystica ph neutral detergent.The instruments came out with rust stains.The instruments were rewashed, and the rust dissolved.The instruments were then ran them through the autoclave process, and the instruments came out with rust stains.The client has a known water problem.The final rinse in the washing process is with reverse osmosis (r.O.) water.The r.O.Water system was offline when the incident happened.The system was cleaned but well water in the area is hard with high iron content.This could be a root cause.However, the rust stains only happen with jarit instruments and not with instruments.The client questioned the following: 1.If the surface texture of the jarit instruments, matte, makes it easy for rust originating in the hospital water system to adhere? 2.If the rust is from impurities leaching out of the devices.Jarit instrument suppliers may be using recycled metal with a higher content of impurities.These device suppliers, even if small companies, need to be audited.The device was returned to the manufacturer for physical evaluation.An investigation of the device manufacturing records was conducted.There were no deviations or non-conformances during the manufacturing process.Two of the three have the tip portion of one blade broken off and missing.The finger ring coating is faded/worn, corrosion stains on the interior blade surface, and no preventive maintenance markings present.Additionally, no bioburden was detected.No manufacturing, workmanship, or material deficiency was identified.Date of manufacture: 02/2004 / 01/2008 / 02/1999.
|
|
Search Alerts/Recalls
|
|
|