MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8.5 MM SI ENDOSCOPE, 30 DEGREE; ENDOSCOPIC INSTRUMENT

Model Number 371939-02

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/22/2015

Event Type  Injury  

Event Description

It was reported that during a da vinci hysterectomy procedure, the lens of the endoscope became blurry.After the endoscope was removed, the surgical staff noticed that the lens was missing.The surgical staff was unsure if the lens had fallen in the patient.The surgeon attempted unsuccessfully to find the lens in the patient.On (b)(6) 2015, intuitive surgical, inc.(isi) contacted the isi technical field specialist (tfs) and received additional information regarding the reported event.According to the tfs, surgical staff removed the endoscope during the middle of the procedure in order to clean off debris that had gotten on the end of the device.After cleaning the endoscope, the device was reinserted into the patient.Upon returning to the surgeon side console (ssc), the surgeon noticed that the vision was blurry.The surgical staff removed the endoscope a second time and then noticed that the lens on the distal end was missing.The surgeon searched for the lens inside the patient but was unable to locate the fragment.The surgical staff did not know if the lens fell out during removal, cleaning, or reinsertion of the endoscope.On (b)(6) 2015, isi contacted the site's clinical manager and a circulator who was present during the surgical procedure.According to the circulator, the vision through the endoscope became a little cloudy during the middle of the surgical procedure.The surgical staff removed the endoscope and cleaned the endoscope using a d-h.E.L.P (defogging heated endoscope lens protector) device.The endoscope was then reinserted into the patient.The circulator indicated that the image was clear for a few seconds and then the image became black.The surgical staff removed endoscope again and noticed that the lens on the distal end was missing.The surgical staff searched for the lens on the d-h.E.L.P device, the surgical trays, and in the patient but were unable to locate the missing piece.The endoscope was replaced and the surgical procedure was completed.No post-operative complications have been reported.The surgeon informed the patient of the missing endoscope lens.

Manufacturer Narrative

The endoscope has been returned to intuitive surgical, inc.(isi) for evaluation.However, at this time the evaluation of the endoscope has not been completed; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted 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 errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: during the da vinci surgical procedure, the lens of the endoscope was found to be missing.At this time, it is unknown if the endoscope lens fell in the patient and was retained.

Manufacturer Narrative

The endoscope was returned to the original equipment manufacturer (oem) for evaluation.The endoscope was received with a missing distal window resulting in fluid invasion and subsequent damage to the optical components.Fragments of adhesive of the distal window were noted to be missing.Based on the additional information provided, this complaint will remain reportable due to the following conclusion: during the da vinci surgical procedure, the lens of the endoscope was found to be missing.At this time, it is still unknown if the endoscope lens actually fell in the patient and was retained.The endoscope was returned, evaluated, and the lens was confirmed to be missing.

• Brand Name: 8.5 MM SI ENDOSCOPE, 30 DEGREE
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 4920135
• MDR Text Key: 15384312
• Report Number: 2955842-2015-01009
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 371939-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention