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Model Number 52969 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical , inc.Is currently investigating the reported condition.
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Event Description
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Customer stated "front part broken".Repair tech stated "complaint verified, replaced socket, diaphragm update, increased power output".Reference repair order # (b)(4).Leep system 1000 esu gen 52969 e-complaint: (b)(4).
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Manufacturer Narrative
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Investigation x: inspect returned samples.Analysis and findings: complaint#: (b)(4).Distribution history: this complaint unit was manufactured on 1/12/2012 under wo#: (b)(4) and shipped on 8/16/2012.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at this time.However, at the time of manufacture, records from each unit are reviewed to ensure that product meet all specifications.Should the device history record be located, this complaint will be amended accordingly.Incoming inspection review: n/a.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log: 95360.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: unit was not functioning properly.Root cause: the unit's front handpiece adaptor socket was broken and attributed to end user handling error.The diaphragm was changed out due to a previous finding where the material degraded to the point where it no longer functioned as intended and prevents activation of a unit.This unit's diaphragm was in working order.However, the corrective action for this issue requires returned units be updated to the new material and applicable on this unit.Correction and/or corrective action: the unit was repaired, tested to specifications and returned to the customer.This unit's diaphragm was also replaced.No further corrective action is necessary.Corrective actions relevant to the updated diaphragm are as follows; engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.No further training required at this time.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.
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Event Description
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Customer stated "front part broken." repair tech stated "complaint verified, replaced socket, diaphragm update, increased power output." reference repair order#: (b)(4).1216677-2020-00318 leep system 1000 esu gen 52969 e-complaint: (b)(4).
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Search Alerts/Recalls
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