MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY DISECTING HOOK; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number SNGHK

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n91m19.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that during an open cabg, it was found that there were two holes on the package before it was opened.The device was not used for the patient.Another device was used to complete the patient.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # n91m19.Investigation summary the analysis results found that snghk device was returned inside its package unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have 2 holes in the tyvek, the holes was noted to be from the outside in.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.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 manufacturing process.

• Brand Name: HS SYNERGY DISECTING HOOK
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7339796
• MDR Text Key: 102494690
• Report Number: 3005075853-2018-08548
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036002816
• UDI-Public: 20705036002816
• Combination Product (y/n): N
• PMA/PMN Number: K012176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: SNGHK
• Device Lot Number: N4LP5J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1