MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. HARMONIC ACE CURVED SHEARS; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 480275-08

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

The harmonic ace curved shears instrument has 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 instrument is returned (post failure analysis) or if additional information is received.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that the tip of the harmonic ace curved shears instrument broke off and fell into the patient.While there was no report of any patient, harm, adverse outcome or injury due to the instrument breakage, recurrence of the reported failure mode could likely cause or contribute to an adverse event.It is unknown what caused the tip of the instrument to break off.

Event Description

On 12-12-2017 intuitive surgical, inc.(isi) received (b)(4) from the fda with the following complaint description: during intraop the da vinci harmonic instrument tip broke off in the patient while in use.The broken tip was retrieved and the instrument was removed immediately.The broken tip aligned with the instrument to make sure all parts were retrieved.No harm was visibly noted to the patient.On 12-22-2017 isi received a copy of the patient's operative report from the site's risk/claims team assistant.According to the information as provided, the patient underwent a da vinci assisted hysterectomy with bilateral salpingectomy procedure on (b)(6) 2017 due to menorrhagia, dysmenorrhea, uterine fibroids and chronic endometriosis.The patient had a uterine fibroid that was about 4 cm at the fundus.The patient also had significant bilateral swollen tubes as well as significant endometriosis especially at the uterosacral ligaments.The information in the operative report indicated that other wise the patient's abdominal and pelvic cavity were normal.According to the information as provided, the harmonic ace instrument was used to dissect the round ligament,the anterior lip of the broad ligament all the way down to the uterocervical junction.The uterine artery was skeletonized and cauterized with an unspecified bipolar instrument and was then cut with the harmonic ace instrument without complications.The patient had a 2 cm ligament fibroid that was dissected from the abdominal wall with the harmonic ace instrument.The vaginal cuff was also excised using the harmonic ace instrument and the hysterectomy was completed.The patient's uterus was then removed vaginally without complications.The operative report indicated that the patient's pelvic cavity was irrigated copiously with warm saline and there was no active bleeding identified.The vaginal cuff was closed, the pelvic cavity was again irrigated copiously with warm saline with no active bleeding identified.The pneumoperitoneum was released up to 3 mmhg, and still no active bleeding was identified.Once this was performed, all the pneumoperitoneum was released and the instruments were removed under direct visualization and the patient was closed.Examination of the patient's vaginal area found a small vaginal wall laceration.Suture was used to repair the defect without complications.A speculum examination was found to be normal.The cystoscope was introduced under direct visualization.The patient's bladder was completely identified and found to be intact.Both ureters were clearly identified with strong jets.According to information in the operative report, the patient's blood loss was minimal and there were no surgical complications.The patient tolerated the procedure well and the patient was transferred to the icu in stable condition.There was no indication in the operative report that any malfunction of the da vinci surgical system, instruments, and/or accessories occurred during the surgical procedure.

• Brand Name: HARMONIC ACE CURVED SHEARS
• 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: 7170835
• MDR Text Key: 97637355
• Report Number: 2955842-2018-00012
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480275-08
• Device Lot Number: M10170619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR