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Verbatim: inadequate light coming from tebbetts retractors.Customer has (4) each of following: 88-1086, 88-1087, 88-1088 and 88-1090.Just for some history.One of the surgeons a week or 2 ago had issue with lack of illumination when using the retractor set.I (biomed) responded and found that they were using a karl storz light source with a 4-way turret on it.Generally, this turret allows for connection of 4 different manufacturer¿s light cables however, the snowden pencer cable does not positively match up to any of them.The light source itself was running at 100% intensity and 43 hrs of a 500 hr bulb life.The nurse was attempting to hold your3mm cable into one of the holes on the turret.Just moving the cable around in that turret has some effect on the amount of light getting to the retractor.I had suggested they try to use our ¿new¿ stryker led light source as at least it accepts your cable better and holds it in place positively.After the case i had the light source and the retractor set brought to me.I tested it a bit with the karl storz xenon light source and did not get what i would consider to be ¿adequate¿ light out of your 3mm cable.I did a comparative, side by side test with your cable and one that i had in my shop that i got from surgical direct for a different application.Very noticeable difference¿ my cable¿ much brighter but, does not fit the retractor set.Then, a 5mm cable was ordered.Once we got that cable, i did some more side-by-side testing between your 3mm and 5mm cable and both light sources.The 5mm was brighter at the distal end as one would assume¿ more fiber¿ more light.There was a case the next morning with the same surgeon, and i asked to make sure he gets the 5mm cable for the case and we would see how it worked.Part way through the case, while stating that it was a little brighter, it was still inadequate at the retractor.The next morning, i got a retractor set from spd and was told that the next to the smallest retractor was what he typically uses.I brought everything to my shop and used a light meter to measure light intensity.I verified the difference between the 3mm and 5mm cables on the storz light source and the stryker.The stryker was a much more positive attachment to the light source and provided a much more consistent and steadier output at the ¿business¿ end of your cables.The storz at 100% actually gets hot enough to start melting the rubber coating on the input end of your cable with visible smoke.I then decided to check the light output with each of the retractor instruments attached.The light output seems to measure close to half of what was available with no instrument attached.In summary: - the size of cable definitely makes a difference on the amount of light getting to the retractor.- the angle of the input connection on the storz makes a difference on the output to the retractor.- the light path from the storz lamp to the distal end of your cable was cleaned with alcohol the stryker led units are still fairly new.- all testing was done @ 100% output of both light sources.- the light output of both light sources is plenty adequate and bright.- once either light source is attached to any of 3 instruments in the tray the light output at the surgical site is diminished.No further information available.
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Verbatim: inadequate light coming from tebbetts retractors.Customer has (4) each of following: 88-1086, 88-1087, 88-1088 and 88-1090.Just for some history.One of the surgeons a week or 2 ago had issue with lack of illumination when using the retractor set.I (biomed) responded and found that they were using a karl storz light source with a 4-way turret on it.Generally, this turret allows for connection of 4 different manufacturer¿s light cables however, the snowden pencer cable does not positively match up to any of them.The light source itself was running at 100% intensity and 43 hrs of a 500 hr bulb life.The nurse was attempting to hold your3mm cable into one of the holes on the turret.Just moving the cable around in that turret has some effect on the amount of light getting to the retractor.I had suggested they try to use our ¿new¿ stryker led light source as at least it accepts your cable better and holds it in place positively.After the case i had the light source and the retractor set brought to me.I tested it a bit with the karl storz xenon light source and did not get what i would consider to be ¿adequate¿ light out of your 3mm cable.I did a comparative, side by side test with your cable and one that i had in my shop that i got from surgical direct for a different application.Very noticeable difference¿ my cable¿ much brighter but, does not fit the retractor set.Then, a 5mm cable was ordered.Once we got that cable, i did some more side-by-side testing between your 3mm and 5mm cable and both light sources.The 5mm was brighter at the distal end as one would assume¿ more fiber¿ more light.There was a case the next morning with the same surgeon, and i asked to make sure he gets the 5mm cable for the case and we would see how it worked.Part way through the case, while stating that it was a little brighter, it was still inadequate at the retractor.The next morning, i got a retractor set from spd and was told that the next to the smallest retractor was what he typically uses.I brought everything to my shop and used a light meter to measure light intensity.I verified the difference between the 3mm and 5mm cables on the storz light source and the stryker.The stryker was a much more positive attachment to the light source and provided a much more consistent and steadier output at the ¿business¿ end of your cables.The storz at 100% actually gets hot enough to start melting the rubber coating on the input end of your cable with visible smoke.I then decided to check the light output with each of the retractor instruments attached.The light output seems to measure close to half of what was available with no instrument attached.In summary: the size of cable definitely makes a difference on the amount of light getting to the retractor.The angle of the input connection on the storz makes a difference on the output to the retractor.The light path from the storz lamp to the distal end of your cable was cleaned with alcohol the stryker led units are still fairly new.All testing was done @ 100% output of both light sources.The light output of both light sources is plenty adequate and bright.Once either light source is attached to any of 3 instruments in the tray the light output at the surgical site is diminished.No further information available.
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Upon receipt the complaint sample received a visual examination and a functional check.The following markings were found on the device: snowden pencer, 88-1088, e21, and 3.5mm.The functional test for the fiber optics is essentially does light pass through or not test, not a minimum threshold test.The reason for this is that fiber optic technology inherently has very low signal attenuation, as in almost all the light passes from one end to the other as the light bounces through the strands.The only loss the fiber optics can experience is the sudden termination of the light, which either exists as terminated strands when the device is inspected prior to being released for distribution, or the strands are not damaged at this point in time.The metal sheath around the fiber optic strands protects the fiber optics from damage through normal use, so the only way to lose light transmission after the retractor is released for distribution is to either damage the fiber optic region of the device through gross mishandling, or by letting deposits build up on the interfacing ends of the fiber optics.There is a critical concept to understand here, the linear transmission of light energy from one end of the fiber optics strands to the other, and from one strand to another.A 3mm cable has a fixed number of strands configured in a circle, a 3.5mm cable has approximately 30% more strands, and a 5mm cable has twice as many strands as a 3.5 mm cable.The cables and fittings do not have any reducer quality where they are capable of focusing the light transmitted in the cable to a smaller size.To reiterate, fiber optic technology does not work like air flow or fluid flow, where a reducer can change the size of the piping, while speeding up the fluid inside, light is already traveling at its maximum speed and a reducer will only cause light to smash into the walls of the coupler and generate heat energy.With the exception of the little bit of dead space inside a coupler between ends of cable strands that allow the light to diffuse and fan out, the light transmitted out of one strand must be met by an immediately adjacent strand to be transmitted.In trying to transmit from a larger cable to a smaller fitting like 5mm to 3.5mm the outer most strands of the 5mm cable will not have any strands in the 3.5mm cable to transmit to, and instead the light will strike bare metal and transition into heat energy.In the instance of trying to transmit from a smaller cable to a larger fitting, like the 3mm cable to the 3.5mm fitting on the retractor, the outermost strands of the retractor will not receive any direct light from cable strands, and the only light they will receive is diffuse light from the dead space in the coupler.Therefore, the use of a larger light source port, or a larger cable does not result in more light, any extra light experienced is not by design, does not comply with the instructions for use (ifu) for this device 36-6269, and is most likely only the result of a little bit of light diffusion in the dead space of the joints.The relationship described above is an explanation for why the cable size requirement stated in the ifu for this device must be followed for these products, the fitting on these retractors is meant to be used with only cables the 3.5 mm and absolutely nothing larger.The 5.0mm fiber optic cable 88-9761 should not be used with these retractors, regardless of light source.The female acmi fitting 88-1060 does not have a bearing on light transmission, provided it maintains the positive connection of the light cable to the retractor while allowing minimal dead space.At this point it is worth clarifying, a 3.5mm cable has approximately 30% more fiber optic strands than a 3mm cable, so using a 3mm cable on a 3.5 mm retractor fitting will result in light 30% dimmer what is capable with a 3.5mm cable.A 5mm cable has approximately twice as many fiber optic strands as the 3.5mm cable, which means approximately half of the light energy transmitted through the 5 mm cable will not be transmitted to the 3.5mm fitting and will instead change into heat energy.Overall, the amount of light emitting from the retractor is dependent on: whether or not the cable fits the light source well and is clear of any soil covering the light source end of the fiber optic strands.Whether or not the cable has a coupler fitted to it that fits the retractor and cable well and that both the retractor fiber optic strands and cable fiber optic strands at that joint are also clear of soil.Whether or not the cable fiber optics have been damaged by mishandling.Whether or not the retractor fiber optics have been damaged by gross mishandling.Whether or not the retractor fiber optics at the distal end are free of soil.Any soil on the mating surface along the path from the light source to the retractor is going to terminate the transmission of light energy and convert the light energy to heat energy.Concerning 88-1088, both ends of the fiber optic retractor were found to not be covered heavily in soil,and were found to transmit light as expected (fiber optic strands are intact).The 5mm fiber optic cable which was sent in with this complaint sample, which should not be used on retractor 88-1088, was found to have a few severed fiber optic strands, but no significant degradation of light transmission was observed.A review of the complaint log was performed, no other complaints were identified for 88-1088 with a date code of e21 were identified to indicate that other customers have experienced similar issues with the same product from the same production batch.The device history record (dhr) was also reviewed, no non-conformances were identified which could have contributed to the complaint failure mode.Concerning the failure mode of smoke-it was not clear whether or not the 3mm cable or 5mm cable was used during this experience, but for either cable to start smoking at the light source end, this means that some of the light energy being generated by the light source was unable to transmit to the cable as light energy, built up as heat energy at the light source-to cable interface, and the cable (and potentially the light source) got hot enough to start smoking.This is most likely a combination of being unable to create a positive connect between the storz light source and the cable, but also indicates the light energy from the light source was not channeled exclusively to the strands of fiber optics inside the cable, but also the metal of the plug, the metal could not transmit the light energy and instead converted it to heat energy.Customer is advised, per the instructions for use for this device, 36-6269, ¿warning: these devices must only be used with a 3.5mm fiber optic bundle cable.Do not use this device with a larger size cable.Failure to use the correctly sized cable will cause the metal connectors of the device/cable to become hot during use and increase the potential of a thermal burn¿ it also states ¿when the device is connected to a light source but not actively in use, keep the light source output off or at the minimum setting.Failure to do so may cause excessive heating of the metal connectors of the fiber optic bundle and the exposed tip and increase the potential of thermal burns.¿ concerning the complaint failure mode of inadequate lighting- as stated before fiber optic strands are either intact and transmitting nearly full light from end to end, or they are terminated and transmitting no late, but generating heat instead.Based on: the fact that the cable, couplers, and device 88-1088, were all functioning as expected, transmitting light without degradation.The absence of other complaints from other customers to indicate a problem common to the production lot this device came from.The absence of a non-conformance in the device history record for this device.What information was given by the customer on the surgical set-up of this device, the most probable root cause of the complaint failure mode is mis-assembly of the surgical set-up.To clarify, for best results, the customer should use a 3.5mm acmi cable, a 3mm cable will result in a dimmer light at the retractors distal end, and the customer should use a light source which is compatible with a 3.5mm acmi fiberoptic cable so that the light source will transmit the light energy fully and exclusively to the fiber optic strands of that cable.
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