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

Model Number 470179-13

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

The mcs instrument and mcs tip cover accessory have not been returned for evaluation, therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the devices are returned (post failure analysis evaluation) or if additional information is received.The initial reporter provided a photographic image of the instrument involved with this case.The photographic image shows a mcs instrument with a broken tube extension at the distal end, at the interface with the proximal clevis.There is also a small area of pad printing that is visibly missing towards the proximal end of the tube extension.The instrument damage was likely caused by misuse/mishandling.If the mcs tip cover accessory is installed properly on the mcs instrument, the instrument accessory will hold broken fragments from the instrument's tube extension inside the tip cover, preventing loss into the patient during the removal of the instrument.In this particular case, it is unclear if the mcs tip cover accessory was installed correctly and it is unknown how the mcs instrument was removed through the cannula.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2016.No related system errors were found to have occurred during the reported surgical procedure.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, a fragment from the tube extension of the mcs instrument allegedly fell inside the patient and was not retrieved.However, it is unknown if the instrument fragment actually fell inside the patient and was retained.Also, there is no indication at this time that a malfunction of a da vinci instrument or accessory occurred.

Event Description

It was initially reported that during a da vinci-assisted colostomy closure procedure, the monopolar curved scissors (mcs) instrument broke and the decision was made to convert to open surgery.According to the initial reporter (an unspecified hospital employee) the patient's pelvis was full of blood during the surgical procedure and the robotic instruments were out of view.Once the instruments were back in view, one of the surgical technicians noticed that part of the orange mcs tube extension was visible.When the mcs instrument was removed by the surgical staff, the mcs tip cover accessory and part of the mcs tube extension were found to be missing.On (b)(6) 2016, the intuitive surgical, inc.(isi) clinical sales representative (csr) provided the following additional information regarding the reported event: the surgical tech inspected the mcs instrument and mcs tip cover accessory prior to the start of the surgical procedure and no issues were found.The surgeon was able to use the mcs instrument without any issues during the surgical procedure and up until the event occurred.At one point during the procedure, the surgical staff had difficulty installing an unspecified suction irrigator instrument.Details regarding the difficulty with installing the suction irrigator instrument are unknown at this time.As a result, the patient's pelvis began to fill with blood, up to the point where the instrument tips were submerged in blood.Although the instrument tips were not readily visible due to the amount of blood in the pelvis, the surgeon attempted to manipulate the colon with the instruments.During this process, the csr concluded that the mcs tip cover accessory that was installed on the mcs instrument, slipped down as a result of multiple instrument collisions.After the surgical staff regained visibility in the pelvis, the surgery tech noticed that the orange part of the mcs instrument's tube extension was exposed.The surgical staff then attempted to remove the mcs instrument.While removing the mcs instrument, the surgery tech had to use some force since the mcs tip cover accessory allegedly got caught along the edge of the cannula.Upon removing the mcs instrument, the surgical staff noticed that the mcs tip cover accessory was missing and the distal end of the mcs instrument was damaged.The surgical staff was able to retrieve the mcs tip cover accessory and most, if not all, of the instrument fragments that might have fallen inside the patient.However, the site was concerned that a very small portion of the orange paint from the tube extension of the mcs instrument had rubbed off during the surgical procedure and was not retrieved.The site performed a post-operative x-ray and the scan was negative.No post-operative complications have been reported as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the monopolar curved scissors (mcs) instrument involved with this complaint and completed investigations.Failure analysis investigations found the instrument with a broken tube extension.In addition, an area from the broken tube extension measuring approximately 0.354 x 0.239 at the tip was found to be missing.The known common cause of this failure is user mishandling/misuse based on the additional information provided, this complaint will remain reportable due to the following conclusion: a broken fragment from the mcs instrument allegedly fell inside the patient and was not retrieved.It is still unknown, however, if the instrument fragment actually fell inside the patient and was retained.Failure analysis of the mcs instrument confirmed that a broken fragment from the instrument was missing.

• 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
• MDR Report Key: 5581091
• MDR Text Key: 42800995
• Report Number: 2955842-2016-00248
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470179-13
• Device Lot Number: S10160109-0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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