|
Concomitant medical products: intuitive surgical, inc.(isi) received the curved-tip stapler 30 instrument (pn: 470530-08 || ln: t10210218 0005) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed nor replicated.The instrument was received with a white reload stuck in the instrument jaw.In-house testing could not be performed.The logs were reviewed and no failures were found.Fa discovered additional findings that were not reported by the site: the instrument was found to have a torn heat shrink at the distal end.Root cause of this failure is attributed to mishandling.The instrument was found to have a broken clamp cardan.No broken pieces were missing.Root cause of this failure is attributed to mishandling.The housing was removed and a broken grip cable was observed.Root cause of this failure is attributed to a component failure.Both the instrument and the reload were referred to an advanced failure analyst (afa) engineer for further investigation and the following was found: the stapler instrument was returned in a clamped state, with a white reload stuck in the jaws and dried tissue was visible on the outside of the jaws.The clamp cardan shell was broken at the weld that retains the pin.No fragments appeared to have separated from the cardan shell.Both the grip open and close cables were broken at the back end.The stapler release kit (srk) did not initially work when attempting to manually unclamp the jaws in-house due to the broken clamp cardan shell causing a disconnection between the input and output shafts within the cardan.However, after the clamp cardan pin was adjusted such that it became partially engaged with the cardan shell, the instrument was able to be manually unclamped.The reload was removed from the channel and looked fine; no blade exposed, no damage to the leadscrew, shuttle, or knife.The fire socket at the crotch of the jaws also looked fine, although there are some loose, formed staples nearby at the dlu pins.The fire cardan did not exhibit any damage on the cardan shell, pin, or weld.The stapler instrument was manually shifted into the fire state and the clutch gear was manually rotated such that the fire cardan rotated.The fire cardan rotated smoothly, there was nothing wrong with the fire drivetrain.Logs showed a drivetrain failure occurring during use of this instrument.However, it appeared that there was a log issue so it was unclear if the drivetrain failure occurred during clamping, firing, or unclamping.Logs showed evidence of an e-stop (emergency stop) press and that the system detected use of the srk on this instrument, both of which occurred after the drivetrain failure was logged.Review of the log details in combination with the visual inspection of the instrument suggests that the instrument experienced a drivetrain failure, possibly as a result of the broken clamp cardan.The broken clamp cardan is potentially caused by mishandling, such as from excessive loading applied to the distal tip of the instrument.The broken grip cable in the backend of the instrument is likely a result of the srk being used, cables may have broken due to the user trying to un-grip by installing and turning the srk in hole 3 (located on top of the stapler backend) prior to fully unclamping the instrument (via hole 2).In addition, the white stapler 30 reload and the stapler release kit (srk) involved with this event were returned and analyzed.Intuitive surgical, inc.(isi) received the white stapler 30 reload (pn: 48630w-02 || ln: n/a ) involved with this complaint and completed the device evaluation.The reload was received stuck in the jaw of the curved-tip stapler 30 instrument.It was noted that the reload could not be visually inspected due to it being stuck in the stapler instrument jaw.Initial root cause of the failure was found to be non-device related factors.Both instrument and the reload were referred to an advanced failure analyst (afa) engineer for further investigation and the following was found: the reload was able to be removed from the stapler 30 instrument from after manually unclamping the instrument in-house.Visual inspection of the reload showed no blade exposed, and no damage to leadscrew, shuttle, or knife.Based on visual inspection, this reload appeared to have completed a firing.Logs were not available for the instrument usage, but the event logs showed a drivetrain failure occurred while the stapler 30 instrument was being used.Based on inspection of the curved-tip stapler 30 instrument, there is no evidence that the drivetrain failure was related to firing.Additionally, the reload does not have any indicators of any firing related issues.The reason the reload could not be removed from the instrument jaws is likely due to the broken clamp cardan on the instrument, which is likely related to the drivetrain failure observed in the event logs.There is no evidence to suggest that the reload had any contribution to the drivetrain failure.Intuitive surgical, inc.(isi) received the stapler release kit; srk (pn: 381215-02 || ln: 623629) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed nor replicated.Due to the stapler release kit (srk) damage, in- house testing could not be performed.The srk was returned with the curved-tip stapler 30 instrument.Visual inspection was conducted and found the srk coupling mechanism twisted at the distal tip.Damage of the srk is a result of overloading during usage.No other damage was found.The root cause of this failure was attributed to mishandling.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted on 07-aug-2021 and again on 16-aug-2021 and no complaints were identified for any other issues with the instrument.No image or video clip for the reported event was submitted for review.System error log review was conducted during the support calls and found two 1164 errors pointing to no stapler cartridge found in the stapler installed on arm 2: ¿no stapler cartridge found in the stapler on usm2¿.There were no other observed arm 2 related errors in the logs prior to the customer trying to remove and release the stapler on arm 2.The following system message was also present: ¿grip release tool detected on usm2 ¿ instrument: stapler 30 curved-tip.The manual grip release wrench while the instrument joints are in a locked state¿.A review of the instrument logs was performed for a procedure on 06-aug-2021 on system sk1611.Endowrist curved-tip stapler 30 pn: 470530-08 || ln: t10210218-0005 || sn: (b)(4) was recorded in use for 0:12:24 (12 minutes and 24 seconds) and was fired three times with white reloads: pn: 48630w-04, and had 34 of 50 uses remaining.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments.An isi field service engineer (fse) investigation was completed.Over the phone, the fse confirmed with an isi clinical sales representative, who was present for the event, that the stapler instrument was removed from the patient and that the site is planning on returning the instrument to isi for analysis.The system was operating within isi specifications.No site visit was required due to same.An isi advanced failure analyst (afa) engineer conducted stapler log review and found the following: log sources found that the issue happened after the third firing with a white reload (color manually selected).A clamp was logged as a drivetrain failure, which typically would prompt a user that the stapler release kit (srk) may be required to manually unclamp.The logs show an e-stop button press following this drivetrain failure and also show that the system detected use of the srk.The sequence of events for the last install are unclear as to the sequence and detail of events.This complaint is considered as a reportable malfunction due to the following: it was alleged that the curved-tip stapler 30 with a white reload failed to unclamp from a vessel when commanded by the user with no evidence or claim of mishandling or misuse.A stapler release kit (srk) was attempted in an effort to release the instrument but the attempts were unsuccessful.Medical intervention may be required in the event that the stapler fails to unclamp from tissue when commanded by the user or system.Additionally, the described event meets the criteria of a reportable adverse event.The surgeon converted the procedure to open surgery because the curved-tip stapler 30 was allegedly clamped closed on a vessel for which medical intervention of clamping, cutting, and suturing was required in order to remove the instrument and resolve the issue.At this time, the root cause of the unclamping event with the need for medical intervention is unknown.
|
|
An intuitive surgical, inc.(isi) clinical sales representative, who was present for the case, reported that during a da vinci-assisted right upper lobe pulmonary lobectomy procedure, a curved-tip stapler 30 s that was installed on universal surgical manipulator (usm) 2, became stuck on the pulmonary artery (pa) as the surgeon clamped and fired the stapler on the third fire with a white reload.The instrument would not unclamp.It was noted that on the 2nd and 3rd fire, the surgeon had manually selected the reload color of white.Isi technical support was contacted for assistance with the use of a stapler release kit (srk) and the system emergency stop (e-stop) button was pressed.Isi support walked the customer through the steps and use of the srk but the instrument did not unclamp.The surgeon converted the procedure to open surgery because the curved-tip stapler 30 was clamped closed on a critical vascular structure.Once the procedure had converted, the surgeon tried to manually open the instrument jaws to release it from the pa but was unsuccessful in the attempt.The surgeon removed the desired lobe specimen and then ¿clamped the pa branch, cold cut it, and sutured on the stay side¿ to safely remove the curved-tip stapler 30 instrument and resolve the issue.The open surgery completed.The patient was reported as doing ¿quite well¿ post-operatively.
|
