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

Model Number	471172-17
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The maryland bipolar forceps instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the maryland bipolar forceps (471172-17/k11220124 0486) associated with this event has been performed.Per logs, the maryland bipolar forceps was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.At this time, it is unknown what caused the thermal damage to occur.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 central processing, the maryland bipolar forceps instrument was observed to have had plastic has burn marks at base of instrument tips.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was completed with no reported injury.The reporter was unsure if the reported issue was also identified during the procedure, but central processing reported the thermal damage.No patient information demographic information is available at this time.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint of burn marks and found the primary failure of thermal damage.The instrument was found to have localized melting near the grip base.This failure is most common caused by insulation degradation and carbonized tissue creating a conductive path.The instrument was placed and driven on an in-house system.The instrument passed the recognition, engagement, energy delivery and electrical continuity tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Common causes of this failure are typically attributed to component failure.Additionally, the instrument was found to have dried residue on the clamping pulleys.Common causes of the failure mode residue instrument clamping pulleys are typically attributed to mishandling/misuse, for example by improper cleaning/reprocessing techniques, such as insufficient flushing.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: 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: 15847434
• Report Number: 2955842-2022-15446
• Device Sequence Number: 6317891
• Product Code: NAY
• UDI-Device Identifier: 00888118114471
• UDI-Public: (01)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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: 471172-17
• Device Catalogue Number: 471172
• Device Lot Number: K11220124 0486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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