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

Catalog Number HAR36

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problem Blood Loss (2597)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.Additional information requested: were you present for the procedure? what is the surgeon¿s typical steps to use the device? (such as waiting for the tone change) were there any issues noted in the initial procedure when attempt to obtain hemostasis with harmonic device? was the har36 used on the short gastric? what other instruments were used during the surgery? was the surgical field inspected and found to be dry (no bleeding) when the patient was closed? how long after the original procedure did the bleeding occur (provided number of hours, days, etc.) what is the patient¿s current condition? did the patient have any pre-existing conditions? did these conditions contribute to the reason to convert to open?.

Event Description

It was reported that the doctor had completed a laparoscopic sleeve gastrectomy and the patient started having blood pressure issues in recovery after the procedure.The doctor reoperated on the patient, performed an open surgery and discovered 1600 cc of blood loss due to a short gastric vessel that hasn't been sealed during the procedure.The patient required a transfusion of two units of blood.The patient was resewed and released to the recovery room.

• Brand Name: HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5258149
• MDR Text Key: 32413974
• Report Number: 3005075853-2015-07666
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: HAR36
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention