MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MEDIUM-LARGE CLIP APPLIER

Model Number	420327-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis replicated and confirmed the customer reported complaint.Failure analysis found the primary failure of failed clip test to be related to the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips clip test was performed and failed.The clip is not properly loaded on the grips.Additional finding related to the primary failure: the clip applier instrument was found with one grip bent.The damage was found near the base of the clip groove, causing a.012" offset at the tips.As a result, the clip could not be properly loaded on the grips.
Event or Problem Description
It was reported that during a da vinci-assisted nephrectomy surgical procedure, the medium-large clip instrument couldn't engage when grasping the vessel on the second trial.The procedure was completed with a backup instrument and completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the or nurse and obtained the following additional information: a weck hem-o-lok medium-large clip applier was used with a green cartridge.The user was able to move the instrument around.The instrument did not misapply the clip.The surgeon confirmed closure of the clip after ligation.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 16926920
• Report Number: 2955842-2023-13300
• Device Sequence Number: 12442560
• Product Code: NAY
• UDI-Device Identifier: 00886874111826
• UDI-Public: (01)00886874111826(10)N10180919
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420327-06
• Device Catalogue Number: 420327
• Device Lot Number: N10180919 457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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