MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARHD36

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022)

Patient Problems Failure to Anastomose (1028); Not Applicable (3189); No Code Available (3191)

Event Date 10/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Following information was requested but unavailable: was it noted during use in the procedure? when the user noticed the hole in the stomach how was it addressed? was it noticed in the initial procedure? was the surgeon aware of the hole in the original procedure? if so, what was done to address? what was the location of the hole? during the re-operation, how was the hole closed? any different usage technique between this device and previous harmonics? how did the leak present? how was it diagnosed? how many days post-op is the leak still continued? what does the surgeon think caused the leak?.

Event Description

It was reported that two days after a laparoscopic sleeve gastrectomy revision procedure the patient returned to the hospital with a leak in their stomach.The patient was re-operated on, the hole was closed, but the leak remains.The patient has been kept in the hospital for observation and been given fluids.The patient could stay in the hospital up to an additional month.The surgeon believes that the hole was originally caused by the clamp arm getting too hot and accidentally poking through the wall of the stomach.

Manufacturer Narrative

(b)(4).Additional information received: was it noted during use in the procedure? no.When the user noticed the hole in stomach how was it addressed? not during original sleeve procedure, but it was corrected the following sunday in surgery.Was it noticed in the initial procedure? no.Was the surgeon aware of the hole in the original procedure? if so, what was done to address? no.What was the location of the hole? higher in stomach near/around fundus.During the re-operation, how was the hole closed? unknown.Any different usage technique between this device and previous harmonics? no, this is a 10+ year experienced harmonic user.How leaks present? unknown.How was it diagnosed? diagnosed after discovering leak, patient re admitted and had the hole corrected on sunday (sleeve procedure was conducted the friday two days before).How many days post-op is the leak still continued? 2 days.What does the surgeon think caused the leak? the thin clamp arm of the new hdi.

• Brand Name: HARMONIC
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7004642
• MDR Text Key: 91183154
• Report Number: 3005075853-2017-05943
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: HARHD36
• Device Lot Number: P93D5X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention