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

Model Number	420110-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of the precise bipolar instrument broke off and fell inside the patient.The fragment was retrieved during the same procedure which was completed with no reported injury.Intuitive surgical, inc.(isi) obtained additional information about the complaint.The instrument was inspected prior to use.There were no cleaning/sterilization processes that recently changed.The precise bipolar instrument was used during the bladder neck dissection.The monopolar curved scissors (mcs) and prograsp forceps instruments were in use when the event occurred.The precise bipolar instrument was replaced by a needle driver but it was removed and reinstalled correctly according to the surgeon.The precise bipolar instrument's wrist was straightened upon removal.The assistant forceps retrieved the fragment safely.There were no intra-operative complications that occurred.The procedure was completed with a backup precise bipolar instrument.Additionally, there was no post-operative complications that occurred and the patients current status had a good clinical evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported issue.The instrument was found to have a broken grip at the grip tip.A piece approximately 0.097" x 0.133" was found to be broken off.The broken piece was returned.This failure is typically associated with mishandling/misuse.Additionally, the instrument was found to have a severely twisted grip, causing side to side movement of the grips.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PRECISE 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: 16925234
• Report Number: 2955842-2023-13152
• Device Sequence Number: 12492742
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N10180406
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050369
• 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): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420110-10
• Device Catalogue Number: 420110
• Device Lot Number: N10180406 834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• 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