MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARHD36

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Code Available (3191)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information obtained: as mentioned in the report, as a result of product defect the procedure converted from an endo procedure to an open procedure and case went on.Patient should be fine now as there was no mention of adverse patient status there after.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.Was the device activated near clips or other instruments? what trouble shooting step prior to converting? any other devices available to finish without converting to open? was patient¿s post-operative care altered? was the reason to convert to open solely because there was no other device available in the facility?.

Event Description

It was reported that during an endo radical harvesting procedure, error message "replace instrument" "instrument error detected" appeared on screen after surgeon only fire (activate device) a few times.Had to resort to conversion to open method of harvesting the radial artery (i.E.Conversion from endo radial harvesting to open radial harvesting).The procedure was completed successfully.

Manufacturer Narrative

(b)(4).Date sent: 5/13/2020.Additional information was requested and the following was received: 1.Was the device activated near clips or other instruments? as endo radial harvesting takes place in a very tight and constrain space, occasional inevitable transient contact with metal retractor or scope might be experienced.2.What trouble shooting step prior to converting? troubleshoot via the gen11 instructions to use existing hd1000i.3.Any other devices available to finish without converting to open? there are new sets of hd1000i available however surgeon refused to open a new piece and he feels its faster to convert to open rather than waiting for the nurses to look for the new hd1000i and setting it up.4.Was patient¿s post-operative care altered? longer wound healing time for the open incision.5.Was the reason to convert to open solely because there was no other device available in the facility? no.Decision to convert because device broke down and surgeon refuse to wait as the new device might break down again (due to the constant space constrain).Upon review of the information provided, the additional information indicated other devices were available for use, it was the surgeon¿s preference to convert to an open procedure.Additionally, the failure modes exhibited by the device does not meet the defined criteria of a reportable adverse event to the fda.

• Brand Name: HARMONIC HD 1000I SHEARS 36CM SHAFT
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10007873
• MDR Text Key: 196413165
• Report Number: 3005075853-2020-02398
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARHD36
• Device Catalogue Number: HARHD36
• Device Lot Number: U93169
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR.