MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.

Event Description

It was reported that a small hole was found in the tyvek before the device was used.It was unknown if this was found while preparing for a procedure or not.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # n91808.The analysis results found that har36 device was returned inside its package.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have hole in the tyvek, the hole was noted to be from the outside in.The area near the hole appears wrinkly and scratched which suggest it was dragged most likely from a rack.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.

• Brand Name: HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY
• 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: 5778881
• MDR Text Key: 49767500
• Report Number: 3005075853-2016-03842
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: HAR36
• Device Lot Number: N91808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1