MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTURE RETRIEVER (BOX 6); SNARE, SURGICAL

Model Number 013593

Device Problem Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an unknown procedure, the suture retriever wire could not come out of the suture retriever.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A review of the drawing indicated that the length of wire loop available was specified.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SUTURE RETRIEVER (BOX 6)
• Type of Device: SNARE, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11117545
• MDR Text Key: 225109254
• Report Number: 1219602-2021-00030
• Device Sequence Number: 1
• Product Code: GAE
• UDI-Device Identifier: 03596010025043
• UDI-Public: 03596010025043
• Combination Product (y/n): N
• PMA/PMN Number: K881224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 013593
• Device Catalogue Number: 013593
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1