MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1756

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Does the surgeon opinion that the wrong needle was attached on one end? can you explain ¿taper point needle and a conventional cutting needle had been jointed¿? do you mean taper point on one end and cutting needle on the other end? do you have any photos of the issue?.

Event Description

It was reported that a patient underwent an unknown ophthalmic procedure on (b)(6) 2017 and suture was used.The surgeon observed the needle under a microscope and it seemed as if a taper point needle and a conventional cutting needle had been jointed.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was obtained: does the surgeon opinion that the wrong needle was attached on one end? ¿yes.Can you explain ¿taper point needle and a conventional cutting needle had been jointed¿? ¿ a taper point needle was attached to one end of the suture, and a conventional cutting needle was attached to the other end.Do you mean taper point on one end and cutting needle on the other end?.Yes.Do you have any photos of the issue? ¿no, we don¿t.

• Brand Name: ETHILON NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6601235
• MDR Text Key: 76314990
• Report Number: 2210968-2017-32342
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946173
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W1756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1