MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. FENESTRATED BIPOLAR FORCEPS; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420205-05

Device Problem Mechanical Jam (2983)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, isi has not determined the root cause for the intra-operative complication experienced by the patient.In addition, the fenestrated bipolar forceps instrument has not been returned to isi 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 failure analysis evaluation) or if additional information is received.A review of the site's system logs with a procedure date of (b)(6) 2015 revealed that no related system errors were found to have occurred during the surgical procedure.The fenestrated bipolar forceps instrument involved with the reported event has been used in subsequent da vinci surgical procedures with no recurrences of the alleged customer reported failure mode.This complaint is being reported due to the following conclusion: the site claimed that unspecified tissue got stuck on the jaws of the fenestrated bipolar forceps instrument and was eventually torn when the surgeon attempted to release the tissue from the instrument.The surgeon reportedly used another instrument to control the bleeding that ensued from the torn tissue.However, at this time, the cause of the tissue getting stuck to the instrument is unknown.

Event Description

It was reported that during a da vinci-assisted hysterectomy procedure, the site's robotic coordinator claimed that unspecified tissue had gotten stuck on the jaws of the fenestrated bipolar forceps instrument.When the surgeon attempted to release the stuck tissue from the instrument, the tissue reportedly tore and bleeding ensued.According to the robotics coordinator, the surgeon was able to control the bleeding with a pk dissecting forceps instrument.The estimated blood loss from the surgical procedure was approximately 300 cc and no blood transfusions were administered.On (b)(6) 2015, an intuitive surgical, inc.(isi) sterile reprocessing specialist (srs) performed reprocessing training with the site's sterile processing department and or staff.The srs explained to the site that the instruments need to be wiped and kept moist in order to avoid any drying of debris and blood during a procedure.The instrument's manual for use states: clean the instruments immediately after each use.Do not allow debris to dry on or inside the instrument intraoperatively before instrument processing.In order to keep the instrument from drying when soiled, keep the instrument in water or an enzymatic bath between the surgical procedure and instrument processing.

• Brand Name: FENESTRATED BIPOLAR FORCEPS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA
• MDR Report Key: 5354521
• MDR Text Key: 35461834
• Report Number: 2955842-2016-00021
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 420205-05
• Device Lot Number: N12150811 668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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
• Patient Outcome(s): Required Intervention