MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PRECISE BIPOLAR FORCEPS

Model Number	420110-12
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the precise bipolar forceps involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The instrument was found to have damage of the conductor wire¿s insulation.This failure is commonly caused by mishandling/misuse, such as collision of the instrument.There was no material missing.The instrument passed the electrical continuity test.The instrument was found to have a bent grip, causing side to side misalignment of the grips.There was a 0.011¿ offset at the tips.The root cause of this failure is attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.The customer reported that the event occurred on (b)(6) 2020, and the instrument had two lives remaining.Upon review of the instrument log for the precise bipolar forceps (420110-12/n11190423 393), the instrument was last used on (b)(6) 2020 on system (b)(4) and has two lives remaining.There is no indication that the instrument was used in subsequent procedures after the event reported on this record.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the bipolar instrument had conductor wire damage, which could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.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 prior to starting a da vinci-assisted prostatectomy surgical procedure, the rubber on the precise bipolar forceps instrument was noted to be broken.The instrument was replaced.There was no report of fragment(s) falling inside the patient.The procedure was completed with no reported injury.Due to the alleged issue, the procedure was delayed by 3 minutes.Intuitive surgical, inc.(isi) has attempted to obtain additional information related to the reported event.However, as of the date of this report, no additional information has been provided.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PRECISE BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11084794
• Report Number: 2955842-2020-11408
• Device Sequence Number: 2849820
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N11190423
• 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: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 420110-12
• Device Catalogue Number: 420110
• Device Lot Number: N11190423 393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Patient Age: 76 YR
• Patient Weight: 69