MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MARYLAND BIPOLAR FORCEPS

Model Number	430010-52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The maryland bipolar forceps instrument was found to have a broken chassis at the location where the nose cover is located.The broken piece was not returned, measuring roughly 1.23 x 0.36 in size.Components adjacent to this broken chassis are missing, like the nose cover.The electrical continuity was performed and passed.The inputs were manually articulated and passed.Additionally, the instrument was found to have a dislodged nose cover.The instrument was visually inspected, and the nose cover measuring roughly 23.36 mm - 9.24 mm was found to be dislodged and not returned due to the damage on the proximal chassis.Additionally, the instrument was found to have one or more of the housing snaps broken.A broken piece was returned, measuring roughly 4.07mm x 5.19mm in size, and two tabs were not returned, measuring roughly 2.11 mm x 2.14 mm.The housing snaps are located within the proximal end of the instrument and secure the housing to the instrument chassis.The instrument was found to have clamping pulley residue.The instrument's housing was removed, and upon inspection, the instrument was found to have an excessive amount of dried, white residue on the clamping pulleys for inputs joggle left/right, yaw, pitch, and joggle up/down, located inside the backend of the instrument.The complaint was confirmed by failure analysis.The probable root cause is attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as an accidental drop of the instrument.Improper cleaning during reprocessing, such as prolonged exposure of the instrument to harsh cleaning agents, can lead to cracking.
Event or Problem Description
It was reported that during central processing, the sp maryland bipolar forceps instrument was found to have a piece missing from the back of the arm.There was no report of fragment falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter; however, the reporter was not able to provide further details.

• Brand Name: ENDOWRIST SP
• Common Device Name: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 25178226
• Report Number: 2955842-2026-25139
• Device Sequence Number: 13437511
• Product Code: NAY
• UDI-Device Identifier: 00886874114322
• UDI-Public: (01)00886874114322(10)S10190620
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 430010-52
• Device Catalogue Number: 430010
• Device Lot Number: S10190620 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2019
• 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: 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