SUPER TURBOVAC 90 IFS
Received Oct 19, 2015 · Event occurred Oct 7, 2015
Report 3006524618-2015-00538 · MDR key 5159707
Device
Generic name
Electrode, Electrosurgical, Active, Foot-controlled, Single Use
Manufacturer
Arthrocare Corp.Catalog number
ASH4250-01
Lot number
1038272
Product problems
- Detachment Of Device Component
- Difficult to Remove
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
VISUAL EVALUATION SHOWED MODERATE ELECTRODE WEAR WITH DISCOLORATION ON THE CAP FROM ACTIVATION. ADHESIVE WAS DETACHED AROUND THE SPACER WITH SCRATCH MARKS PRESENT ON THE CAP. THERE WERE ALSO SCRATCH AND SCUFF MARKS ON THE BLACK SHRINK TUBE FROM THE TIP TO THE HANDLE OF THE DEVICE. THE CUSTOMER¿S COMPLAINT WAS VISUALLY VERIFIED AND THE ROOT CAUSE IS MOST LIKELY ASSOCIATED WITH COMING INTO CONTACT WITH A SHARP OR HARD OBJECT, SUCH AS A CANNULA. IT IS POSSIBLE THAT UPON INSERTION OR REMOVAL OF THE DEVICE, USING A CANNULA, THE TIP INADVERTENTLY CAME INTO CONTACT WITH THE CANNULA BOUNDARIES, THEREFORE CAUSING THE ADHESIVE TO BECOME DETACHED. THE INSTRUCTIONS FOR USE OUTLINES WARNINGS AND PRECAUTIONARY MEASURES TO ADHERE TO DURING ACTIVATION OF THE DEVICE. THERE ARE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A SUPER TURBOVAC 90 IFS WAND, AFTER 7 MINUTES OF ACTIVATION THE SURGEON ALLEGED THAT THE PLASTIC RING ON THE WAND TIP DETACHED WHILE IN THE SURGICAL SITE. THE SURGEON WAS ABLE TO RETRIEVE PART OF THE PLASTIC, BUT DECIDED TO ABANDON SOME DEBRIS IN THE TISSUE BECAUSE IT WAS HARD TO REMOVE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.