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U.S. Department of Health and Human Services


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Model Number 470298-14
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has not received the stapler 45 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 and evaluated and/ or if additional information is received. A review of the instrument logs for the stapler 45 instrument (part# 470298-14 / sn: (b)(4)) associated with this event was performed. The instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 25 uses remaining. Based on this review, the instrument was not used in subsequent procedures after the alleged event reported in this event. A review of the site's complaint history does not show any additional complaints related to this product. No image or video clip for the reported event was submitted for review. An isi) failure analysis engineer (fae) reviewed dsp logs that showed that the stapler 45 pn 470298-14, lot t10210812-0008 was installed 4x and fired 3 reloads (all green). First three installs resulted in completed clamp/fire/unclamp per the logs. On the 4th install (also using a green reload), the instrument had 4 incomplete clamps, and failed to unclamp following the 4th incomplete clamp. The unclamp failed at 22% completion. There is an error 22030 in the msc logs that also confirms the unclamp failure. There is no evidence in the msc logs that the site pressed the e-stop button or that the system detected use of the stapler release kit (srk) on the instrument. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the stapler 45 was stuck inside the patient. The customer was able to remove the stapler 45 instrument and surgeon then switched to a handheld stapler. It was alleged that the staples became stuck and/or lodged to the reload cartridge after firing, with unknown cause. Medical intervention may be required in the event that the staple cannot be released from the target tissue. 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 pulmonary lobectomy surgical procedure, the customer had a stapler 45 stuck inside the patient. The customer was able to remove the stapler 45 instrument and the surgeon then switched to a handheld stapler. The customer stated that no patient injury occurred and the procedure was completed as planned with no patient harm. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
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Type of DeviceSTAPLER 45
Manufacturer (Section D)
3410 central expressway
santa clara CA
Manufacturer (Section G)
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
MDR Report Key13565422
MDR Text Key296394222
Report Number2955842-2022-10305
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470298-14
Device Catalogue Number470298
Device Lot NumberT10210812 0008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/19/2022 Patient Sequence Number: 1