MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD WHITE

Model Number	48360W-08
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unspecified da vinci-assisted procedure, bleeding occurred from a staple line created with a sureform 60 stapler instrument loaded with a white sureform 60 stapler reload.Further details regarding the issue that occurred, the amount of unexpected bleeding, any medical interventions required, and any other information regarding the event are unknown.Intuitive surgical, inc.(isi) contacted the site for additional information, and the customer responded that they were unable to provide further details regarding the event.
Additional Manufacturer Narrative
Based on the current information provided, the cause of the intraoperative complication cannot be determined.The product has not been returned to intuitive surgical, inc.For evaluation.A review of the system and instrument logs could not be completed, due to insufficient information.This issue was also reported against a blue sureform 60 stapler reload via mfr report number 2955842-2023-21673.It is unknown which reload contributed to the bleeding or if both reloads contributed to the event.Blank mdr fields: 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.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received three white sureform 60 stapler reloads associated with this complaint, and failure analysis (fa) investigations were completed.Fa did not replicate nor confirm the customer reported complaint.A visual inspection was performed, and all three reloads appeared to be used and fired without any issues.There was no external physical damage observed.The reloads were disassembled in-house for inspection, and there was no damage found.There were no problems detected, and no product issue was identified.Issues related to instrument errors or to complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.Isi also received the sureform 60 stapler instrument associated with this complaint, and an fa investigation was completed.Fa did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on the in-house system with a cannula seal and an in-house drape installed, and it passed engagement 3 out of 3 times.The instrument also passed initialization, and it passed the recognition and engagement tests multiple times.The instrument moved intuitively, with full range of motion in all directions, and the jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was successfully fired with white and blue sureform 60 stapler reloads.A visual inspection was performed, and no damage was observed.No problem was detected during the analysis and testing.According to the logs, the stapler successfully clamped, fired, and unclamped five times.Three of these successful fires were performed using white sureform 60 stapler reloads, one of which was manually selected by the customer.The other two successful fires were performed using blue sureform 60 stapler reloads, and for both reloads, the color was manually selected from the surgeon console.Isi received the following additional information from the customer: the bleeding was observed from small vessels in the mesentery.The monopolar curved scissors and bipolar energy from an unspecified instrument were used to successfully control the bleeding.The bleeding was not expected; the estimated amount of blood loss was less than 50ml.No blood transfusions were required.Anatomical factors did not cause the bleeding.Per the surgeon, the bleeding was observed from the staple line.The white reloads were used for the mesentery, and the blue reloads were used for the small intestine.When using the white reloads through the mesentery, you could see bleeding from the staple line afterwards.There were no malformed or unformed staple present, the reloads did not have exposed blades, there were no staples missing from the staple line, there were no holes or gaps observed within the stapler line, and the reload was not stuck to tissue.No other details were provided.This issue was also reported against a blue sureform 60 stapler reload via mfr report number 2955842-2023-21673.It is unknown which reload contributed to the bleeding or if both reloads contributed to the event.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 18415337
• Report Number: 2955842-2023-21672
• Device Sequence Number: 2933176
• Product Code: GDW
• UDI-Device Identifier: 10886874113827
• UDI-Public: (01)10886874113827(10)K12221117
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 48360W-08
• Device Catalogue Number: 48360W
• Device Lot Number: K12221117
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: Unknown
• 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