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

Model Number	48630G-04
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information provided, the cause of the operative complication cannot be determined.Intuitive surgical, inc.(isi) has received the endowrist 30 stapler green reload involved with this complaint for failure analysis evaluation and completed investigations.Failure analysis investigations found the reload to have a lodged staple, stuck in between the reload pocket and the pusher.The common cause of this failure is attributed to the user.Additionally, the reload was found to have a damaged pusher.The common cause of this failure is attributed to a component failure.A follow-up mdr will be submitted if additional information is obtained.A system log review was performed for this procedure: no relevant errors were observed during this procedure.An advanced instrument log review was performed for this procedure by an isi advanced failure analysis engineer (afa).Per afa, the tool table showed that pn 470530-08, lot t10220627-0036 fired 4 reloads and pn 470530-08, lot t10220421-0008 fired 1 reload.The only reload colors in the tool table were white and green.Logs show one firing failure (error code 22030 with p1=1) with lot t10220627-0036 at 21:17:17 pm and another firing failure with lot t10220421-0008 at 21:22:14 pm.Each instrument had a firing failure, but cannot confirm what colors were used or other firing related details like completion pct.No image or video clips for the reported event were submitted by the customer for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, two endowrist 30 curved tip stapler instruments experienced firing failures.The endowrist 30 stapler (bn: 0036) cut across the staple line; the surgeon believes that the cutting blade of the green stapler 30 reload went past the staple line and cut the bronchus.A second backup endowrist 30 stapler (bn: 0008) was then installed to attempt to staple across the staple line, but it also encountered a firing failure while using a green stapler 30 reload.Again, malformed staples were observed.The cause of the operative complication is unknown.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, two endowrist 30 curved tip stapler instruments experienced firing failures.The issue occurred while stapling across the left upper bronchus.The initial endowrist 30 stapler (bn: 0036) did not go through the entire release sequence, stopping hallway through without finishing, while installed in universal surgical manipulator 1 (usm1).This occurred during the fourth fire with a green reload.White reloads were used prior to the green without issue.The endowrist 30 stapler cut across the staple line; the surgeon believes that the cutting blade went past the staple line and cut the bronchus.Malformed staples were observed.A second backup endowrist 30 stapler (bn: 0008) was then installed to attempt to staple across the staple line, but it also encountered a firing failure while using a green reload.The one and only attempted fire with the second endowrist 30 stapler went across previous staples.Malformed staples were observed.The firing failure issues occurred with green reloads in both endowrist 30 staplers.The technical service engineer viewed the live logs and noted engagement errors on usm1.Per tse recommendation, the usm drape was reseated.A cadiere forceps instrument was installed in usm1 and used in between the first and second endowrist 30 staplers without issues.A sureform 45 stapler was installed into usm3 and was successfully able to complete a fire of that stapler using a white reload.The procedure was completed as planned with no reported injury.

• 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: 15785508
• Report Number: 2955842-2022-15214
• Device Sequence Number: 4674217
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M90220508
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: M90220508 0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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: Reuse
• 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