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

Catalog Number HARH36

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during a laparoscopic hysterectomy procedure, after several activations the white teflon pad came off.The teflon pad did fall into the patient but could be retrieved without leaving any material inside the patient.It seems that the teflon pad did not properly adhere to the anvil, both the shear and the teflon pad will be sent in.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Batch # n90c6f.The analysis results found that the device was received with the tissue pad detached and returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test hand piece and a gen11 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 record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.

• 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: 5672750
• MDR Text Key: 45976778
• Report Number: 3005075853-2016-02905
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

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: 01/08/2021
• Device Catalogue Number: HARH36
• Device Lot Number: N90C6F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1