MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; STAPLER 45

Model Number 410298-11

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed but did not replicate the customer reported complaint of "stapler would not fire properly." failure analysis found the primary finding of an unclamping failure to be related to the customer reported complaint.The stapler 45 instrument was found to have an unclamp failure based on a log review.Additional findings not reported by site: the stapler 45 instrument was found to have a bent pivot tube.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the distal end of the instrument.No functional test could be performed due to the bent pivot tube.The stapler 45 instrument was unable to be placed on the system since it would not go through the cannula.The root cause of the bent pivot tube is attributed to the user.The stapler 45 instrument was found to have a broken grip cable at the proximal end.As a result, the stapler 45 instrument was unable to open or close.The root cause of the broken cable is attributed to a component failure.The stapler 45 instrument was found to have tears on the heat shrink that goes over the conductor wire.The electrical continuity test was performed and passed.The root cause of the torn heat shrink is attributed to the user.A review of the site's complaint history revealed that the stapler 45 green reload and the stapler sheath used during this procedure were also returned for failure analysis.The stapler 45 green reload was returned unused.The knife of the stapler 45 green reload was seated in the garage at the proximal end, as expected.There was no damage to the cartridge.The stapler sheath was observed to have no damage.The stapler sheath was installed on an in-house stapler instrument with no issues found.A review of the instrument log showed the stapler 45 instrument (part #410298-11 / lot #s10150626-116) was last used on (b)(6) 2019 during this reported procedure with system (b)(4).The stapler 45 instrument has 50 allotted uses and 10 lives left.The stapler 45 instrument has not been used in subsequent procedures after the alleged event reported on this record.The stapler 45 green reload and stapler sheath information cannot be verified through the system log review.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the stapler 45 instrument was unable to unclamp the instrument jaws.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the stapler 45 instrument would not fire properly.The stapler 45 instrument reportedly "made a weird noise during calibration of the third firing sequence." an error message occurred stating "failure to unclamp." the stapler 45 instrument was able to complete 2 fires prior to the issue.The customer used a stapler release kit (srk) to release the stapler 45 instrument.The customer replaced the stapler 45 instrument with a backup instrument of the same kind and continued with the case.The procedure was completed with no report of patient harm, injury or adverse outcome.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the procedure was a robotic lung thoracoscopy with decortication and biopsy.The customer reported the stapler 45 instrument was grasping on tissue when the issue occurred; however, there was no patient harm.There was no partial fire.The target tissue was the right lung lower lobe.The patient had not undergone any previous chemotherapy or radiation treatments.The integrity of the patient's tissue was good.The surgeon did not encounter any obstructions between the jaws of the stapler 45 instrument.A stapler 45 green reload was used and was selected based on tissue thickness.No buttress material was used.In addition, the patient's tissue did not appear to be too thick.No tissue bunching was observed in the jaws of the stapler 45 instrument.There are no photographic images or a video recording of the procedure.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10925903
• MDR Text Key: 241078945
• Report Number: 2955842-2020-11283
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093(10)S10150626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410298-11
• Device Catalogue Number: 410298
• Device Lot Number: S10150626 116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1