MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problem Loose or Intermittent Connection (1371)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information is unavailable; device not returned.No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Batch #unk.The batch history records were reviewed and the manufacturing criteria was met prior to the release of the batches include in this lot.

Event Description

It was reported that during an unknown procedure the device loosed the tissue pad inside the patient, the foreign body removed from the patient with forceps and discarded.Another like device was used to complete the case.No patient consequences.

Manufacturer Narrative

(b)(64.Batch #m90j6r.The device was returned with tissue pad detached but with evidence of the tissue pad material in the groove section of the clamp arm.The device was connected to a test hand piece and generator and the device did activate during functional testing.The device was disassembled to inspect the internal components and no anomalies were found.Based on the condition of the tissue pad, a probable cause of this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.The batch history records were reviewed with no anomalies noted during the manufacturing process.

• Brand Name: HARMONIC ACE + 7
• 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: 4960638
• MDR Text Key: 23324193
• Report Number: 3005075853-2015-04891
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/22/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2020
• Device Catalogue Number: HARH36
• Device Lot Number: M90J6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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