MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; DAVINCI SI; FUNDUS GRASPER

Model Number	428058-14
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not received the fundus grasper instrument for evaluation.Therefore, the root cause of the customer reported failure cannot be determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.Based on the information provided at this time, this complaint is being reported because plastic fragments came off the fundus grasper instrument and fell inside the patient.The fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the plastic piece holding the fundus grasper instrument jaws together broke when the surgeon attempted to grasp a catheter.The jaws, plastic, and pin fell inside the patient.The procedure was completed with no reported injury.On 07/16/2019, intuitive surgical, inc.(isi) followed up with the clinical territory associate (csa) and obtained the following additional information: all fragments were retrieved during the same procedure with robotic and laparoscopic instruments.The instrument was not removed during the procedure.There were no post-operative tests performed and the patient had not returned to the hospital due to experiencing post-surgical complications related to retaining a foreign object.Isi also followed up with the surgeon and obtained the following additional information: while in routine use during the case, the metallic tips of the instrument came apart.The surgeon stated that after retrieval of all of the pieces it appears the plastic housing on one of the two sides had fractured, leading the connecting pin to fall out and one of the two grasping ends to become dislodged.This issue occurred while grabbing onto a cholangiogram catheter which is a fairly soft 2-3 mm wide piece of plastic, but had been used for several minutes during the normal course of dissection leading up to that time.The surgeon stated that the instrument was on its 3rd of 5 lives and suspects there could have been a non visible fracture in the instrument's plastic piece prior to starting the case which under the stress of use became a full fracture resulting in the failure.The surgeon indicated it would be hard to see this even on careful inspection as the piece itself is quite small.

• Brand Name: SINGLE-SITE; DAVINCI SI
• Common Device Name: FUNDUS GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8837367
• Report Number: 2955842-2019-10566
• Device Sequence Number: 19479779
• Product Code: NAY
• UDI-Device Identifier: 00886874111956
• UDI-Public: (01)00886874111956(10)N10180711
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: 428058-14
• Device Lot Number: N10180711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1