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

Model Number 471172-17

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the user observed a preceived "unintended energization" of an energy instrument.The customer received phone assistance from the technical support engineer (tse).Upon verification, user confirmed the following connections on the system: universal side manipulator (usm) arm 1: fenestrated bipolar forceps instrument connected to the iesu - viodv generator, usm arm 2: endoscope, usm arm 3: vessel sealer instrument connected to e-100 generator, usm arm 4: cadiere forceps instrument and an external force triad generator connected to a maryland bipolar forceps instrument.Upon verification, user noted that they observed an energy activation audible alert from the external force triad generator when they pressed the left energy activation pedal.The user indicated that the issue resolved after verifying the connections.User was unable to confirm if the energy instrument actually fired energy or otherwise.Tse's review of the system logs confirmed no related error fault.The user continued the procedure with no further issue reported.No fragment fell into the patient.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event from the isi clinical sales representative who was present during the procedure: the system and instruments were inspected prior to use.It was confirmed that the energy instrument (mbf instrument) that was connected to the external generator was not inside the patient and was not in use for a surgical task at the time of unintended energy activation.No known impact or patient consequence was confirmed.

Manufacturer Narrative

Based on the claim against the product by the customer, an investigation was completed to determine the cause of this reported event.Follow up confirmed that the maryland bipolar forceps instrument is not returning to isi for evaluation.Although the complaint was not confirmed by failure analysis since the maryland bipolar forceps instrument was not returned, the information gathered indicates that the device did contribute to the customer reported issue.A review of the instrument log for the xi®/xi dual/x¿ maryland bipolar forceps instrument lot# k11220209 / sequence 0041 associated with this event has been performed.Per logs, the instrument was used for a procedure on the reported event date of (b)(6) 2023 and no subsequent use recorded after last usage.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: 17348255
• MDR Text Key: 319338399
• Report Number: 2955842-2023-17156
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K11220209
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-17
• Device Catalogue Number: 471172
• Device Lot Number: K11220209 0041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES