MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM MONOPOLAR CURVED SCISSORS; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 470179-14

Device Problems Fracture (1260); Device Issue (2379); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Isi has reviewed the site's system logs with a procedure date of (b)(6) 2017.Based on the available system logs, no related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: after the mcs instrument was returned to isi and evaluated for a reported loose cable issue, failure analysis identified a missing fragment.At this time, the location of the missing instrument fragment is unknown.It is unknown if the missing instrument fragment possibly fell inside the patient and was retained inside the patient.

Event Description

It was reported that a loose cable was found on the monopolar curved scissors (mcs) instrument at the site's sterile processing department (spd).There were no reports of any patient harm.The mcs instrument was returned to intuitive surgical, inc.(isi) and evaluated.The instrument was found to have a loose grip cable with no visible cable damage at the wrist.The grip input spun freely without corresponding output motion at the distal end, suggesting a failure on the back end.The house was removed and one grip cable was found to be broken at the clamping pulley.An additional observation found that was not reported by the customer was a broken tube extension on the instrument.Material measuring approximately 0.24 x 0.11 was found to be missing and was not returned with the instrument.The clevis was also found to be dislodged from the tube extension.The known common cause of this failure is mishandling/misuse.The instrument was also found with degradation throughout the entire main tube from proximal to distal end.The surface of the main tube was slightly discolored and no longer smooth.No material appeared to be missing.The known common cause of this failure is improper cleaning.On 11/10/2017, isi notified the site of the missing instrument fragment that was found with the evaluation of the instrument.On 11/28/2017, isi contacted the site's robotics coordinator and obtained the following information regarding the reported event: the robotics coordinator stated that she inspects each instrument prior to sending to isi for evaluation.She could not recall identifying any damage to the instrument's tube extension during her inspection of the instrument.She did not know when the instrument's tube extension actually broke.The robotics coordinator indicated that she was going to review the video for the surgical procedure.On 12/13/2017, isi contacted the robotics coordinator again.The robotics coordinator indicated that she reviewed the video of the surgical procedure and did not find any evidence of the instrument's tube extension breaking during the case.The robotics coordinator also spoke to the surgeon and a surgical tech who was present during the surgical procedure.At no point during the surgical procedure did they notice that the tube extension of the instrument was broken.The robotics coordinator indicated that she believes the instrument likely broke during the shipping transit of the instrument to isi.She also stated that they are 99.9% sure no instrument fragments fell inside the patient.

• Brand Name: 8 MM MONOPOLAR CURVED SCISSORS
• 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 ; 4085232420
• MDR Report Key: 7121886
• MDR Text Key: 94992128
• Report Number: 2955842-2017-00847
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112298
• UDI-Public: (01)00886874112298(10)N10161014
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470179-14
• Device Lot Number: N10161014 0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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): Other