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Model Number 470183-14 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has not yet received the permanent cautery hook (pch) instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.A review of the instrument log showed the pch instrument (part #470183-14 / lot #n10181205-0032) was last used on 17-mar-2021 during this reported procedure with system (b)(4).The pch instrument has 10 allotted uses and had 0 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to the pch instrument.No image or video clip for the reported event was submitted to isi for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: during a da vinci-assisted cholecystectomy surgical procedure, it was alleged that a plastic piece on the pch instrument broke and a fragment potentially fell inside the patient.At this time, it is unknown what caused the breakage to occur, whether a fragment fell inside the patient, and the location of the fragment if there was one.
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Event Description
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It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer noted the permanent cautery hook (pch) instrument was not behaving properly.The customer examined the pch instrument and found a plastic piece (where the pin holds the hook) was broken off.The intuitive surgical, inc.(isi) clinical sales representative (csr) also inspected the pch instrument and confirmed the plastic piece was missing.The customer looked for fragment(s) inside the patient, and nothing was found.The customer noted the fragment(s) did not fall inside the patient during an instrument tip collision.The wrist of the pch was straightened upon removal.There are photographic images of the device/fragment(s) or a video recording of the procedure.The customer replaced the pch instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.The customer also reported the patient was doing fine at that point.Isi obtained the following additional information regarding the reported event: the csr was not present during the surgical procedure.The additional information was obtained from the surgeon and operating room staff.The pch instrument was reportedly inspected prior to use, and no issues were noted.However, the surgeon believes the pch instrument was fractured prior to the case.The pch instrument performed as intended for 15 minutes up until it broke.It is unknown what surgical task was being performed at the time of the instrument breakage.To the customer¿s knowledge, the pch instrument did not make contact with any other instrument or hard material during the surgical procedure.The surgeon noted that it felt like the articulation was not functioning correctly, and it was difficult to remove the pch instrument.The pch instrument was eventually removed from the patient.There was resistance when removing the pch instrument through the cannula.The surgeon had to use another instrument to straighten the pch instrument for removal.After the pch instrument was removed from the patient, the surgical staff noticed that there was no damage to the cannula.However, there was a fractured piece of plastic on the pch instrument.It is still unknown if there was a fragment missing from the instrument and the location of the fragment if there was.No additional surgical procedure was required.There were no post-operative tests performed to check for remaining fragments.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The pch instrument is available for return to isi for evaluation.No patient-related information was available.Although requested, no image or video clip for the reported event was submitted for review.
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Search Alerts/Recalls
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