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Model Number 471093-11 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has not received the prograsp forceps instrument for evaluation, although it is expected to be returned.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.Verification of the event details via system logs cannot be performed at this time because a full instrument lot sequence number was not provided by the customer.A review of the site's complaint history does not show any additional complaints for this product.Review of the provided image are consistent with the report of a broken prograsp forceps instrument at the distal tip.The root cause of the failure mode cannot be confirmed without the returned device.This complaint is being reported based on the following conclusion: it was alleged that the prograsp forceps instrument broke during a da vinci assisted procedure and it is unknown if a fragment fell inside the patient.At this time it is unknown what caused the breakage to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date in section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h4 is blank because insufficient product information was provided in order to obtain the date of manufacture.
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Event Description
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It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the prograsp forceps instrument broke at the distal tip.The operating room team removed the instrument along with the cannula out of the patient.The procedure was completed and there was no known impact or patient consequence reported.Per subsequent follow-up, the customer confirmed that the prograsp forceps instrument shaft broke approximately 15 minutes into the procedure.The instrument was inspected prior to use and no abnormalities were observed.The customer confirmed the operating room team did not see any fragment fall inside the patient.However; it was also indicated that it cannot be excluded due to the damage to the instrument.The procedure was completed with a backup instrument with no patient harm and a procedural delay of five minutes.
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Manufacturer Narrative
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Additional information can be found in the following sections: d4, d9, g3, g6, h2, h3, and h4 analysis information can be found in the following fields: intuitive surgical, inc.(isi) has received the prograsp forceps instrument associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint that the prograsp forceps instrument broke at the distal tip.Failure analysis found the primary failure of broken main tube to be related to the customer reported complaint.The instrument was found to have the main tube broken.A piece measuring roughly 0.127¿ x 0.325¿ was not returned with the instrument.The main tube and distal tip remained intact due to the cables all being undamaged.However, the instrument cannot be placed on an in-house system for any functional testing due the inability to feed through the cannula.The root cause is typically attributed to mishandling/misuse.A review of the instrument log for the prograsp forceps instrument (part# 471093-11/lot# k10211101 0353) associated with this event has been performed.Per logs, the instrument was last used for a procedure on 14 march 2022 using system sl0310.The instrument had 17 remaining usable lives with no subsequent use recorded.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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