Getinge became aware of an issue with one of the surgical lights - hled 700.It was stated oil was coming out of the spring arm.We decided to report the issue in abundance of caution as oil falling off into sterile field or during procedure may cause contamination.According to the information obtained from the getinge service technician, the device has been cleaned and returned to use.It was established that when the event occurred, the surgical light did not meet its specification due to oil leakage from hled surgical light, which contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.During the investigation, it was found that in the past the reported scenario has never lead to serious injury nor death.Comparing the number of involved devices to the install base, we conclude that the failure ratio is for the allegation of oil leakage is low.As stated by the subject matter expert at the manufacturer¿s site, during the assembly of spring arms the supplier applies a creamed grease turning into liquid above 135°c.So, the black dripping liquid observed cannot come from the spring arm itself but finds its origin elsewhere.The first cause is a combination of air conditioning and an excess of oil at the bushing location between the spring arm and the main arm.And according to the latest technical investigations carried out in august 2020 at maquet sas the second probable root cause would be an excess of cleaning product in the lower part of the spring arm, applied in spray or with a sponge, but not in compliance with the recommendations given in our user manual.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
|