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

Catalog Number HARH36

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please, explain the meaning of ¿kept on when not activating? did the device activate when the switch buttons were not depressed?.

Event Description

It was reported that during a bilateral salpingo oophorectomy procedure, the device kept turning off in the middle of activation and kept on when not activating.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Information was not provided by the contact.Information anticipated, but unavailable at this time.Batch # ni.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please, explain the meaning of ¿kept on when not activating? did the device activate when the switch buttons were not depressed?.

Event Description

It was reported that during a bilateral salpingo oophorectomy procedure, the device kept turning off in the middle of activation and kept on when not activating.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # m9176j.Conclusion: the device was returned in good physical condition.The device was tested with a generator and was functional, activating when each of the max and min activation buttons were pressed, but no continuous activation occurred during any functional testing.The device was disassembled to examine the condition of the internal activation components and no anomalies were noted.It could not be determined why reportedly the device kept being activated after releasing the activation buttons.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: 4925416
• MDR Text Key: 22508998
• Report Number: 3005075853-2015-04409
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 06/29/2015

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: 04/01/2020
• Device Catalogue Number: HARH36
• Device Lot Number: M9176J
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2015
• 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