MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM TIP-UP FENESTRATEDGRASPER; ENDOSCOPIC INSTRUMENT

Model Number 470347-09

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Failure analysis confirmed the customer reported event and found the instrument to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from the instrument clevis.The clevis did not exhibit any damage or wear marks and other cables at the instrument wrist were not damaged.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the site alleged that the instrument broke.Post-operatively it was determined that the instrument fragment fell inside the patient, and the instrument fragment was not retrieved.The site stated that an x-ray confirmed that an instrument fragment was still retained inside the patient.

Event Description

It was initially reported that during a da vinci-assisted procedure, an unspecified wire snapped on the tip-up fenestrated grasper instrument.There was no report of fragments falling inside the patient, patient harm, adverse outcome or injury.On 02/09/2018 intuitive surgical, inc.(isi) received fda voluntary report mw5074496 with the following event description: during the robotic portion of the surgery, the tip-up fenestrated grasper stopped working and was removed from the abdomen by dr.(b)(6).Upon visual inspection of the instrument, one of the wires was no longer intact.The instrument was not used for the remainder of the procedure.Wire thought to have snapped in half during case.Pt returned to ed for back pain and an x-ray was taken for that cc.At that time a small (less than 9 mm) piece of frayed wire was seen in pt- rfo.Isi contacted the isi clinical sales representative (csr) and the site's risk manager and received the following additional information regarding the reported event: the patient underwent da vinci-assisted hemicolectomy procedure on (b)(6) 2017.As per the surgeon's operative notes, it was reported that the tip-up fenestrated grasper instrument had malfunctioned during the procedure, and the instrument was removed.On inspection, the instrument seemed to have been intact.On postoperative day one, the patient experienced neck pain.As a result, the patient had a total spine x-ray done.The finding was as follows: an 8 mm curvilinear metallic density seen in the projection of the right abdomen, which may represent a retained body.The risk manager stated that the surgeon consulted with an interventional radiologist and decided that the risks of removing the foreign object surgically outweigh the benefits.As per the risk manager, the fragment is still retained inside the patient.The risk manager confirmed that the patient was informed about the retained foreign body in her abdomen.

• Brand Name: 8 MM TIP-UP FENESTRATEDGRASPER
• Type of Device: ENDOSCOPIC 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: 7306322
• MDR Text Key: 101271588
• Report Number: 2955842-2018-00108
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10170830
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470347-09
• Device Lot Number: N10170830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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