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Model Number 470298-12
Device Problem Difficult to Remove (1528)
Patient Problem Abscess (1690)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative
4315. Based on the current information provided, the root cause of the patient¿s post-operative complication cannot be determined. Intuitive has received the stapler 45 instrument associated with this complaint and completed investigations. Failure analysis investigations confirmed the customer reported complaint that the stapler instrument could not be removed properly. Review of system logs showed that a stapler reload was fired completely but the user clamped again, and then attempted to remove the stapler instrument without unclamping. As a result, the stapler is in a clamped state and cannot open up the grip housing while outside the system arm without using the stapler release kit (srk). The standard clinical workflow following a completed fire is for the system to automatically unclamp, which should reflect in the logs as two shift events (shifting from fire to roll, then from roll to clamp) followed by an unclamp event. Review of system logs showed that after the last completed firing event with this instrument, the two expected shift events appear, along with an unexpected clamp event, and two "unknown state" events. The system logs show a non-recoverable error 26002 occurring at the same time as the unexpected clamp and unknown state events. Error 26002 details indicate an execution of a clamp command failed. Since the error 26002 is non-recoverable, the user would have had to use the srk to manually unclamp the jaws, which is mentioned in the complaint. The system logs also show evidence of e-stop button presses following the error 26002. E-stop press is the first step in srk instructions. An additional observation not reported was a broken grip cable at the wrist. Intuitive motion was not being experienced upon manual input of the disk knobs. The broken cable segment that contains the crimp was missing from its slot. The missing crimp was approximately 0. 046¿ x 0. 032. ¿ any potential fragments would have been retained by the stapler sheath. A follow-up mdr will be submitted if additional information is received. Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2019. No related system errors were found to have occurred during the surgical procedure. This complaint is being reported due to the following: after undergoing a da vinci-assisted surgical procedure, the patient experienced a post-operative abscess that was treated conservatively. At this time, the root cause of the post-operative complication is unknown. It is unclear if the post-operative complication is even related to the stapling issue experienced by the surgical staff.
Event Description
It was initially reported that during a da vinci-assisted low anterior resection procedure, the stapler 45 instrument was unable to be removed after it was fired. The stapler release kit (srk) was used to remove the instrument. There were no fragments that fell inside of the patient's anatomy. The procedure was completed with a delay of approximately 30 minutes with no adverse effect or injury to the patient. Per the site, the associated reload was discarded and will not be returned for evaluation. On (b)(6) 2019, intuitive surgical, inc. (isi) contacted the initial reporter and obtained the following additional information regarding the reported event: the surgical procedure was not recorded on video. The instrument was inspected prior to use. At the time the event occurred, the initial reporter believed the surgeon was ¿trying to close the jaws. ¿ the target tissue was rectum. There was no tissue tension or tissue bundles. In addition, the target tissue was not exposed to any prior radiation or chemotherapy. While using the stapler 45 instrument, the surgeon had encountered obstacles which were staples. The surgical procedure was not completed with a replacement stapler instrument. Post-operatively, the patient developed an ¿abscess formation on the rectum that was treated conservatively. ¿ in regards to the patient¿s current condition, the patient was noted to be ¿doing well. ¿.
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Type of DeviceSTAPLER 45
Manufacturer (Section D)
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
MDR Report Key9329749
MDR Text Key166743779
Report Number2955842-2019-10900
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number470298-12
Device Lot NumberT10181016 0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/15/2019 Patient Sequence Number: 1