MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD WHITE

Model Number	48630W
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy, while using an endowrist 30 curved-tip stapler instrument with a white stapler 30 reload on a vessel, the surgeon experienced a partial fire.Through follow up with the or clinicians, it was learned that there were no holes or gaps in the staple line, bleeding, or malformed staples observed.However, they did experience an exposed blade.In order to continue the staple line, additional tissue had to be dissected further up in order to fire the next reload with the backup stapler.
Additional Manufacturer Narrative
Based on the current information provided, the cause of the partial fire is unknown.The product has not been returned to intuitive surgical, inc.(isi) for evaluation.A follow-up mdr will be submitted if additional information is obtained.A review of the logs show an endowrist 30 curved-tip stapler instrument was installed on the system 14 times and fired 8 reloads (2 white, 3 blue, 3 white, in that order).On installations 1-5, clamping and firing were completed successfully with no errors in the logs.On installations 6 and 7, the logs show an error code indicating that there was no stapler cartridge detected by the system upon the install of the instrument.No clamping or firing was attempted on these installations.On installation 8, the system failed to communicate with the reload, this time prompting the user to select the white reload color via the the surgeon side console (ssc) touchpad.Clamping and firing were then successfully completed.On installation 9, there were 2 additional instances of error code 1164 in the logs, this time with parameters indicating that the detect load unit (dlu) pins in the stapler jaws had been shorted.No clamping or firing was attempted on this installation.Installation 10 was successful, however the system again failed to communicate with the reload, prompting the user to select the white reload color via the gui on the ssc touchpad.No clamping or firing was attempted on this installation.On installation 11, there was another instance of error code 1164, stating that the dlu pins may have been shorted.No clamping or firing was attempted.On installation 12, the user selected the white reload color and clamping and firing were completed successfully.On installation 13, another error shows in the logs indicating no stapler cartridge was detected in the jaws.The instrument was removed and installed for the 14th time.The white reload was selected by the user and clamping was completed successfully.This was followed by a firing failure, which stopped at ~44% completion.The logs show an error code with parameters of the error indicating that the failure occurred due to high torque detected during the firing.There were no other errors for this instrument in the logs.In summary: installs 6, 7, 9, 10, 11, and 13 all had issues with detecting the reload that was installed and no clamping or firing was attempted on these installs.Install 14 had a firing failure due to high torque during the firing.There were no incomplete clamps, or incomplete unclamps.There are no system errors in the logs that would have caused or contributed to the reported event.This complaint has been reported due to the following conclusion: during a da vinci-assisted surgical procedure, a firing failure occurred during use of the endowrist stapler 30 curved-tip stapler instrument with a white stapler 30 reload installed.The firing issue occurred while stapling a vessel which resulted in the need to resect additional tissue in order to continue the staple line.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Device evaluation: the endowrist stapler 30 curved-tip instrument was returned with the white endowrist 30 instrument reload and instrument sheath for failure analysis (fa) investigation.During analysis of the endowrist stapler 30 curved-tip instrument, the failure was confirmed via the system logs but not replicated during fa where the instrument was installed on an in-house system and passed initialization tests, moved intuitively with full range of motion in all directions and clamped and fired successfully.The customer reported complaint of an exposed blade on the white reload was confirmed as the cartridge was not found to have damage but, the knife was exposed within the knife track.The root cause of the exposed blade is not determinable.While not mentioned in the initial report, the stapler sheath was also returned for analysis and was found to have a tear on the proximal end measuring 0.017" x 0.023" with no material missing.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD WHITE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16826985
• Report Number: 2955842-2023-12240
• Device Sequence Number: 6849664
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)M90211004
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48630W
• Device Catalogue Number: 48630W
• Device Lot Number: M90211004 1165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White