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

Model Number	48630W-04
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy, the endowrist stapler 30 instrument produced malformed staples, a small clip applier instrument was used to seal the tissue, and the procedure was completed robotically.During follow-up with the robotics coordinator (roco), it was stated that after firing the stapler, the surgeon noticed the staples were not closed all the way.The staples were not removed.Instead, the small clip applier instrument was used over the staples.No other intervention(s) were needed.
Additional Manufacturer Narrative
The endowrist stapler 30 curved-tip instrument, nor a reload used in the procedure, was returned to intuitive surgical, inc.(isi) for analysis.During follow-up, it was stated that the stapler would not be returned.Failure analysis showed that each of the returned reloads was unopened.Advanced stapler logs show the instrument was installed on the system 2 times and fired two white reloads.On install 1, the reload lot number k10230926-0125 (implicated reload) was installed, and clamping and firing were completed successfully.On install 2, the second white reload was installed, and clamping and firing were completed successfully.The instrument was then removed and not used again in the procedure.No relevant stapler-related errors were in the system logs.Section d10 concomitant products: endowrist 30 stapler curved-tip instrument (part number: 470530-8 | lot number: t10231120-0010).
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information: based on the reported event, the only used reload returned by the site for rma, lot number: k10230926, does not match the lot number of the implicated reload, lot number: k11231012.However, during follow up, the site stated the associated reload was returned - suggesting the site implicated the incorrect lot number initially.During failure analysis it was found that the used reload had all pushers deployed and no unformed staples found.The blade was at the distal end and not exposed and there was no blade or cartridge damage found.While the reload was used in the reported complaint, it is unclear if it was the reload associated with the malformed staples.
Additional Manufacturer Narrative
Correction: the only used stapler 30 reload returned for failure analysis was lot number: k11231012-0406 (not k10230926 as previously stated).While it was confirmed k11231012-0406 was used during the procedure, it was not the lot (k10230926) implicated by the customer.Intuitive surgical, inc.(isi) received seven white stapler 30 reloads.All seven stapler reloads were returned without being used.No damage was found.The stapler reloads were installed in an in-house instrument and then placed on an in-house system.The stapler reloads were fired without issues.All the pushers were deployed and the staples formed onto test sheets.The blade of each stapler reload was at the distal end and not exposed.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 19043662
• Report Number: 2955842-2024-12936
• Device Sequence Number: 18260616
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)K10230926
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2024

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-04
• Device Catalogue Number: 48630W
• Device Lot Number: K10230926 0125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 01/10/2025
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/18/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: Asian