It was reported that the new cottle nasal spec sz 4 55mm (400143) "were about to be put in the instrument trays when the damaged instruments were noticed".The user reportedly "received metal splinters imbedded in the thumb and fingers, requiring forceps to remove the metal splinters"."product has imperfections regarding the instrument finish, and metal splinters are being shed, resulting in physical injury of the user." the user was not permanently injured and did not have to seek medical assistance for injury.It was reported that the device was not used in procedure, thus no patient impact and no delay in procedure occurred.
|
The cottle nasal specs sz 4 55mm ((b)(6)) wee returned to the supplier for further analysis: per the supplier, visual inspection revealed no burrs or sharp edges.For both parts, functionality was checked, especially the rounded, knurled knob / set screw and the threated rod were moved and touched, but no sharp edges or metal splinters came off or hurt skin of the test user.Thus, complaint could not be retraced and it could not be confirmed that metal splinters came off these parts.However, it could be confirmed that the set screw looked worn, and surface was not as smooth as it normally looks like when newly produced.Review of the device history record showed device in conformance to specifications at time of release.Complaint history was reviewed and no similar issued has been registered so far.Items in stock were also checked and no part had burr or sharp edges.Especially, the surface of the set screws was inspected, and no deviations could be identified.In conclusion, it could be confirmed that the returned product looked worn, and surface of the set screw was not in specification compared to a newly produced product.However, sharp edges or splinters that may have come off the set screw could not be confirmed.Furthermore, no other product problems could be identified that might have contributed to the described complaint.The root cause remains unclarified.According to the reported event, the metal splinters appeared while instruments were put into an instruments tray.One possible cause could be that the splinters came off an instrument nearby or the tray itself and were associated with the instruments of complaint by mistake.Misuse of the product such as twisting the set screw with pliers may have led to the described type of damage/surface issue of the set crew.No manufacturing, workmanship or material deficiency has been identified.
|