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Issue is being investigated by manufacturing site.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.Device not returned to manufacturer.
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On 24th october, 2019 getinge received customer product complaint where an issue with one of surgical light occurred - lucea.As it was stated, the crack of the cover occurred and particles were missing.There were no injuries reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.
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On 24th october, 2019 getinge received customer product complaint where an issue with one of surgical light occurred - lucea.As it was stated, the crack of the cover occurred and particles were missing.There were no injuries reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.The device involved in the event is lucea 100-100 with serial number (b)(6).It was established that when the event occurred, the surgical light did not meet its specification due to headlight¿s covers detachment and it contributed to the issue.It is unknown if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have investigated the issue.Unfortunately, the specific root cause wasn¿t possible to be established due to lack of information, despite our best efforts.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.
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The purpose of this submission is solely to provide a correction of additional manufacturer narrative/corrected data section (h10) and event problem and evaluation codes (h6).This is based on the result of an internal review.#h6: evaluation result codes- previous: no findings avialable (3221).Evaluation result codes- corrected: maintnance problem (115).Evaluation conclusion codes- previous: cause not established (4315).Evaluation conclusion codes- corrected: cause traced to maintenance (51).#h10: previous: on 24th october, 2019 getinge received customer product complaint where an issue with one of surgical light occurred - lucea.As it was stated, the crack of the cover occurred and particles were missing.There were no injuries reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to contamination.The device involved in the event is lucea 100-100 with serial number (b)(6).It was established that when the event occurred, the surgical light did not meet its specification due to headlight¿s covers detachment and it contributed to the issue.It is unknown if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have investigated the issue.Unfortunately, the specific root cause wasn¿t possible to be established due to lack of information, despite our best efforts.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.Corrected: this follow up report is based on the on the second revision of the investigation.The manufacturer performed review of complaints closed with the root cause ¿impossible to define¿ and decided to update related investigation as after the review it was concluded that the most probable root cause could be established.On 24th october, 2019 getinge became aware of an issue with a surgical light lucea100.As it was stated, the plastic cover was cracked which resulted in missing particles.There was no injury reported however, we decided to report the issue based on the potential as any parts or particles falling off may lead to the surgical field contamination.Device involved in the event has serial number (b)(6).It was established that when the event occurred, the surgical light did not meet its specification and it contributed to described event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to the serious injury or worse, to death.As it was confirmed by subject matter experts from the manufacturing site the most likely root cause of the situation occurrence is related to the combination of different factors: mechanical stress, use of inappropriate cleaning/disinfection products, or inappropriate cleaning and disinfection protocols.For cleaning, the ifu informs the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and to use inappropriate disinfectants.However, the test performed showed that the aggressive cleaning agents can lead to the situation under this investigation only in combination with a mechanical stress.Cracks located on the light head lower covers, at the edge of the on/off button, were detected during daily visual inspection, as recommended by the user manual.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.We believe that devices in the market are performing correctly overall.We also find the issue as highly detectable during daily visual inspection which is an important step given in the user manual.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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