MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON 10-0 CS160-6 D*; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number U7000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.When was the issue noted: before use/during suturing/other- explain)? do you mean the particle dropped off while the device was being used on the patient? were there any adverse patient consequences due to this issue? if yes, what medical/surgical intervention was provided? is the product available for evaluation and being returned? lot number.

Event Description

It was reported that a patient underwent an ophthalmology procedure on an unknown date and suture was used.It was reported that a pearl of glue was seen on the suture at the swage.The pearl of glue possibly dislocated and got loose.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: were two devices used in the same procedure? no, this problem has emerged in several cases, where one of the mentioned codes have been used.When was the issue noted for each device; before use/during suturing/other- explain)? during use.One picture shows an isolated foreign particle retrieved from operation site, do you mean the particle dropped off while the device was being used on the patient? yes, in some cases it stayed on the suture, sometimes it dropped off.Were there any adverse patient consequences due to this issue? no, all dislocated pearls of glue have been retrieved.If yes, what medical/surgical intervention was provided? is the product available for evaluation and being returned? no.Lot numbers not known.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.You reported "this problem has emerged in several cases, where one of the mentioned codes have been used." were the prior events reported? what are the pc numbers? please open a pc for each event.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8787114
• MDR Text Key: 150976835
• Report Number: 2210968-2019-84248
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: U7000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Patient Sequence Number: 1