MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Codes	No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse replaced the affected patient side manipulator (psm) to resolve the reported problem.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) also received the patient side manipulator (psm) involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed and reproduced the customer reported complaint.During failure analysis, the psm was installed onto the test system and reproduced the reported failure (insertion stuck) during power up.Friction readings were found to be out of spec along axis 1 during evaluation.The axis brake will be replaced as a fix.The complaint patient side manipulator (psm) with clamp had an insertion failure was confirmed based on the field evaluation and failure analysis, which indicated that the device did contribute to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted nephrectomy surgical procedure, the patient side manipulator (psm) with clamp had an insertion failure.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the field service engineer (fse) and obtained the following additional information: the system powered on without errors and system functionality was checked upon powering on the system.The clinical sales representative was present during the procedure and contacted support when the issue occurred.The fse provided troubleshooting on how to recover from the reported problem, but the issue persisted.The fse advised that the affected psm could be disabled allowing the user to complete the procedure with the remaining arms; however, the surgeon made the decision to convert the procedure to traditional laparoscopic techniques with no patient injury reported.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 17067482
• Report Number: 2955842-2023-15798
• Device Sequence Number: 12434527
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: 380686-04
• Device Catalogue Number: 380686
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White