Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.Follow-up report #1 is to provide fda with the results of the device investigation (product history evaluation) regarding this mdr.New information: the following fields have new information: b4, b5, g6, h2, h3 (not returned to manufacturer), h6 (type of investigation, investigation findings, investigation conclusion), and h10.The results of the request for device return: on july 6, 2022, rwmic has requested the user facility for the return of the device.A repair return authorization document no.200421455, (form 3043 08) has been issued.Currently, rwmic has no record of device being returned.Since device was not returned, the manufacturer, rwgmbh, has performed and completed a product history evaluation in lieu of the actual device investigation.The results of the product history evaluation: (rwgmbh, investigation report product histroy evaluation, form 5253 (00).Dated, 10/25/2022.The reported device rigid grasp forceps 5fr wl 430mm 8642.65 from batch #4500170290 was produced on 06/18/2015 and it contains 43 pieces.All 43 pieces were sold to rwmic till 07/29/2015.Rwgmbh has no records about when the affected end user received the device in question.There is no other complaints from the same batch.Since the reported device won't be returned for investigation, the root cause of the malfunction cannot be determined.Based on the received information as well as on older complaints, the probable root cause of the reported issue is mechanical overload.The complaint database at rwgmbh has been reviewed between 01/01/2019 and 07/16/2022.Rwgmbh has recorded 3 complaints regarding the device 8642.65: 700017515 from belgium.700018299 / 22-00185 (current complaint) from the us.The device of complaint (b)(4) was returned for investigation.The root cause of the reported issue of complaint (b)(4) was mechanical overload.The devices of the following complaints were not returned for investigation: 70017391 / 21-00129.700018299 / 22-00185 (current complaint).The product history evaluations are available for these complaints.In the relevant ifu ga-e193 / usa / 2011-08 v1.0 / eco 2011-0319, the user is advised in section 5 checks about the control of the device for damage and completeness as well as in section 6 application about the limited strength of the device.In the relevant risk assessment p08fo015 risk assessment - b 1-2: reusable non-optical forceps and scissors, rev.R05, the possible risk due to failure of the corresponding extend of damage and the assumed probability of occurrence and probability of reoccurrence were considered and assessed as an acceptable risk.Rwgmbh considers this mdr closed.An additional report will be submitted if new information becomes available.
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