MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; DOUBLE FENESTRATED GRASPER

Model Number	420189-12
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting that non-intuitive movement, an investigation was completed to determine the cause of this reported event.Although the complaint regarding reported failure was not confirmed by failure analysis since the instrument was not returned, the information gathered indicates that the device did contribute to the customer reported issue.This complaint is considered a reportable event due to the following conclusion: it was alleged that the instrument moved in the opposite motion.Unintuitive motion can result to subsequent tissue damage.At this time, the root cause of the failure is unknown.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the user observed non-intuitive movement (moved in the opposite direction) on the instrument installed on patient side manipulator (psm) arm 3.The customer received phone assistance from the technical support engineer (tse).Troubleshooting was performed by testing the same instrument into another psm arm; however, the issue persisted.Review of the site¿s system logs identified no related error.The surgeon elected to continue with the procedure.At an unspecified time, customer called back and informed that the same instrument was retested, and the same issue was observed.The user stopped using the affected instrument.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: an inspection and check was conducted on the system and the instrument prior to use.The instruments worked initially.The double fenestrated grasper instrument exhibited an issue, and it was replaced with a backup instrument.The procedure was completed using all psm arms.No known impact or patient consequence was reported.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: DOUBLE FENESTRATED GRASPER
• 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: 16593217
• Report Number: 2955842-2023-11469
• Device Sequence Number: 4937431
• Product Code: NAY
• UDI-Device Identifier: 00886874111581
• UDI-Public: (01)00886874111581(10)N10210830
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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: 420189-12
• Device Catalogue Number: 420189
• Device Lot Number: N10210830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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