MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLUE

Model Number	48345B-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, intuitive surgical, inc.(isi) received fda voluntary report with mdr report #mw5145176 stating "three (3) incidents of a sureform 45 stapler malfunctioning and misfiring and in the last 4 months.Lot #t10221003 ref(b)(4), exp: 10/31/2024.Reference reports: mw5145175, mw5145177.".
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.Although the complaint was not confirmed by failure analysis since the product was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.Note: refer to medwatch report (mdr) with patient identifier #(b)(6) for mdr submission of the event referencing fda voluntary report mw5145175.Note: refer to medwatch report (mdr) with patient identifier #(b)(6) for mdr submission of the event referencing fda voluntary report mw5145177.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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: 17927340
• Report Number: 2955842-2023-19155
• Device Sequence Number: 15152306
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)T10221003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: 48345B-01
• Device Catalogue Number: 48345B
• Device Lot Number: T10221003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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