MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*REUSABLE NDL HOLDER; HOLDER, NEEDLE

Catalog Number SRNH1

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the instructions for use received for the self righting needle holder is for the united states and not for (b)(6)."this instrument has come to us with american ifus that state the sterilisation should be at 134 for 5 minutes." no patient involvement occurred.

• Type of Device: HOLDER, NEEDLE
• 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: 7263127
• MDR Text Key: 99995355
• Report Number: 3005075853-2018-07916
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SRNH1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1