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

Model Number	48630G-04
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information, the causes of the customer reported failure mode and operative complication cannot be determined.The product has not been returned to isi for evaluation.A follow-up mdr will be submitted if additional information is obtained.An isi advanced failure analysis engineer (fae) conducted a stapler log review and found the following: the logs show curved-tip stapler 30 instrument (part #470530-08, lot #t10210916-0025) was used first and was installed on the system 1 time on universal surgical manipulator (usm) #4.This stapler instrument fired 1 white reload.There was one clamp and fire by this instrument and both were completed successfully.There were no errors in the logs for this instrument.Next, the logs show curved-tip stapler 30 instrument (part #470530-08, lot #t10200731-0032) was installed 2 times, first on usm #2 and next on usm #4.The instrument fired two reloads (1 white, followed by 1 green).The first install of this instrument had no errors and clamping and firing was completed successfully.On the 2nd install, there was a completed clamp followed by a firing failure at around 41% completion.The logs show error code 22030 and indicate that the torque was too high when firing.There were no other errors for this instrument in the logs.Based on the logs, it is likely that the green stapler 30 reload was the reload involved with the reported incident.Image(s) and/or video clip(s) associated with this reported event were not submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, an incomplete staple line was identified after a stapler 30 reload was fired with a curved-tip stapler 30 instrument.As a result, the staple line was oozing.The surgeon used a new stapler instrument and fired another reload to resolve the complication.The causes of the customer reported failure mode and operative complication are unknown.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, an incomplete staple line was identified after a green stapler 30 reload was fired with a curved-tip stapler 30 instrument.As a result, the staple line was oozing.Intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: the csr stated she had discussed the incident with the surgeon.The surgeon fired a curved-tip stapler 30 instrument on unspecified tissue (unknown reload color and which staple fire).The stapler instrument made a grinding noise and would not complete the fire.An unspecified error message indicating a firing issue was generated.An incomplete staple line and oozing were identified in addition to some malformed staples.As a result of the stapling issue, a new unspecified stapler instrument was opened by the surgical staff and the surgeon fired another reload.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed but not did not replicate the customer-reported complaint.Failure analysis found the primary failure of a failed functional firing test to be related to the customer reported complaint.For clarification, the instrument was found to have a firing failure based on log review, but it was not replicated during in-house testing.The instrument was placed and driven on an in-house system.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler initialized, clamped, fired, and unclamped without any issues.The root cause is not determinable/applicable in instances such as this.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD GREEN
• 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: 15965684
• Report Number: 2955842-2022-15878
• Device Sequence Number: 5550327
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M10220713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/14/2022

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M10220713 0677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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 Sex: Unknown