MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK10-0 30 2XTGW140-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1770

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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 possibly dislocated and got loose.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).Device evaluation summary: no device returned; only pictures of the sample were received for analysis.Upon visual inspection of the picture, a samples with an excess of epoxy at the attachment area could be observed.The manufacturing record evaluation review could not be conducted, because the batch number of the complaint is unknown.The single complaint was reported with multiple events.There are no additional details regarding the additional events.If further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: you reported "this problem has emerged in several cases, where one of the mentioned codes have been used." were the prior events reported? we have no details about the individual cases; we don¿t know the dates, the number, the codes used etc.This was the first time we have heard about the problem, so no other complaints have been registered.Without any details it will be difficult to open new complaints.

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/12/2019.The photo upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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: 8787084
• MDR Text Key: 150979317
• Report Number: 2210968-2019-84247
• 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,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: W1770
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 08/13/2019
• Supplement Dates FDA Received: 08/12/2019; 09/06/2019
• Patient Sequence Number: 1