MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC* BLUE HAND PIECE AND BLUE TEST TIP

Catalog Number HPBLUE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) information asked for but unknown or not provided during initial contact.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Event Description

It was reported that during an open pancreatectomy, water leaked from the joint line of silver housing assemblies during the operation.The water seemed to be a cleaning liquid.Gen04 was used.Another device was used to complete the case.There were no adverse consequences to the patient.When the device was checked at our technical service, the event was not recreated.

Manufacturer Narrative

(b)(4).Additional information: handpiece received in good condition.There was no visual damaged to the handpiece hoising.Some black marks on the gold rings.The handpiece was functionally tested on a gen11 generator.Generator showed 79 uses remaining; 199 hz phase margin and 24.59 ohms.Conforming specifications.The handpiece was also functionally tested ona gen04 generator and the handpiece pass pre-run and user initiated testing.The handpiece was connected to a test fcs17 device and the fcs17 cut the test media.The handpiece was disassembled and debris was found between the mid-housing and the endcap.The moisture indicator was negative.The handpiece was conforming.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch.

• 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: 5320971
• MDR Text Key: 34918242
• Report Number: 3005075853-2015-08316
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063192
• 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: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPBLUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1