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

Model Number 470172-16

Device Problem Electrical Shorting (2926)

Patient Problem Burn(s) (1757)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Intuitive has received the maryland bipolar forceps instrument associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip opened and closed properly.Upon visual inspection, there was no physical damage at the wrist.The instrument was tested for electrical continuity and failed.The housing was removed for inspection and the instrument was found to have a broken conductor wire in the main tube the proximal end.No signs of thermal damage were observed.The damage to the conductor wire likely occurred during the assembly process.If a conductor wire is damaged with bare conductors in contact with the hypotube, tissue burning at the wrist is more easily achieved for normal positioning/contact.Based on the information provided, this event is being reported due to the following conclusion: it was reported that during a da vinci-assisted total hysterectomy surgical procedure, the maryland bipolar forceps instrument burned the uterine tissue at the wrist instead of the jaws of the instrument.It was confirmed that the burned tissue was intended to be removed as a part of the planned surgical procedure, hence no medical intervention was rendered.The conductor wire damage with no evidence or claim of user mishandling or misuse found during failure analysis suggests that if the malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure, the maryland bipolar forceps instrument burned the uterine tissue at the wrist instead of the jaws of the instrument.There was limited burning at the tip of the maryland bipolar forceps instrument.The procedure was completed with no reported injury.On 22-may-2019, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: it was stated that while the surgeon activated the bipolar energy to coagulate the ovarian ligament and artery, it was observed that the uterine tissue was burned at the wrist versus the tip of the maryland bipolar forceps instrument.The csr also confirmed that the tissue that was burnt and removed was part of the planned surgical procedure.The other instruments used at that time were the monopolar curved scissors and tip-up instruments.However, they were not in close proximity to the maryland bipolar forceps instrument.It was confirmed that the instruments were inspected prior to use and there was no video recording of the procedure.

• Brand Name: ENDOWRIST
• Type of Device: ,MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• Manufacturer Contact: izabel nielson ; 950 kifer rd.; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 8723492
• MDR Text Key: 199455599
• Report Number: 2955842-2019-10474
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2019

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
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Lot Number: N10181226 0136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1