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

Model Number	48630B-04
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci assisted pulmonary lobectomy, the surgeon fired a curved-tip stapler 30 instruments on the bronchus and the knife blade of a stapler reload allegedly got "bumped off the track." it was explained that during the procedure, the surgeon had used a blue stapler reload and experienced an incomplete staple line.The surgeon then decided to use a green stapler reload but was unsuccessful.At that time, the surgeon decided to convert to an open procedure to complete the resection with a third-party handheld stapler and then proceeded to close the operative site with a muscle flap.It was noted that the patient had very calcified, thickened tissue which may have caused the stapler to not complete the stapling process.The initial reporter confirmed that there were no intraoperative stapler or stapler engagement issues and that the curved tip-up 30 stapler instrument would not be returned for evaluation.Additionally, the stapler reloads would not be returned to isi for evaluation, as they have been discarded.
Additional Manufacturer Narrative
Based on the information provided, the root cause of the intraoperative complication and customer reported failure mode cannot be determined.It is unknown if the intraoperative issue was related to anatomical/clinical reasons or a product issue.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted for the procedure date of (b)(6) 2021 and did not show any additional complaints related to this product.The stapler instruments and reloads used during the procedure have been discarded.Therefore, no products are expected to return to intuitive surgical, inc.(isi) for failure analysis evaluation.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments.A review of the stapler logs for the curved tip-up stapler 30 instrument associated with this event has been completed.The tool table show shows 13 stapler reloads (5 blue, 5 white, and 3 green) were fired by a curved-tip stapler 30 instrument (part #470530-08, lot #t10210111-0011), however the order in which they were fired or the firing results (pass/fail) are unknown.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, the surgeon fired a curved-tip stapler 30 instrument on the bronchus but the transection of the tissue was incomplete.The patient¿s bronchus was very calcified and it is suspected that it is why the stapling failure occurred.As a result, the surgeon converted to open surgery and completed the transection with a third-party stapler instrument.At this time, the root cause of the alleged event is unknown.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.
Additional Manufacturer Narrative
Based on the information provided, the root cause of the intraoperative complication and customer reported failure mode cannot be determined.It is unknown if the intraoperative issue was related to anatomical/clinical reasons or a product issue.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted for the procedure date of (b)(6) 2021 and did not show any additional complaints related to this product.The stapler instruments and reloads used during the procedure have been discarded.Therefore, no products are expected to return to intuitive surgical, inc.(isi) for failure analysis evaluation.A review of the system and instrument logs has been performed.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments.A review of the stapler logs for the curved tip-up stapler 30 instrument associated with this event has been completed.The tool table show shows 13 stapler reloads (5 blue, 5 white, and 3 green) were fired by a curved-tip stapler 30 instrument (part #470530-08, lot #t10210111-0011), however the order in which they were fired or the firing results (pass/fail) are unknown.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, the surgeon fired a curved-tip stapler 30 instrument on the bronchus but the transection of the tissue was incomplete.The patient¿s bronchus was very calcified and it is suspected that it is why the stapling failure occurred.As a result, the surgeon converted to open surgery and completed the transection with a third-party stapler instrument.At this time, the root cause of the alleged event is unknown.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.
Event or Problem Description
It was reported that during a da vinci assisted pulmonary lobectomy, the surgeon fired a curved-tip stapler 30 instruments on the bronchus and the knife blade of a stapler reload allegedly got "bumped off the track." it was explained that during the procedure, the surgeon had used a blue stapler reload and experienced an incomplete staple line.The surgeon then decided to use a green stapler reload but was unsuccessful.At that time, the surgeon decided to convert to an open procedure to complete the resection with a third-party handheld stapler and then proceeded to close the operative site with a muscle flap.It was noted that the patient had very calcified, thickened tissue which may have caused the stapler to not complete the stapling process.The initial reporter confirmed that there were no intraoperative stapler or stapler engagement issues and that the curved tip-up 30 stapler instrument would not be returned for evaluation.Additionally, the stapler reloads would not be returned to isi for evaluation, as they have been discarded.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just an adverse event as previously reported due to the report of there being an allegation of a blue load 30mm stapler failure due to the blade becoming exposed, which could potentially be related to a product problem.After the first attempt, the left-over staples from the first staple line contributed to the subsequent misfires.Corrected information can be found in the following field: b1 updated to " adverse event and product problem" from " adverse event".Updated fields: g3, g6, h2, h10.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD
• 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: 13060842
• Report Number: 2955842-2021-11794
• Device Sequence Number: 1427607
• Product Code: GDW
• UDI-Device Identifier: 10886874112837
• UDI-Public: (01)10886874112837(10)M90210517
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 48630B-04
• Device Catalogue Number: 48630B
• Device Lot Number: M90210517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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 Sex: Unknown