MAUDE Adverse Event Report: VIANT MEDICAL OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-SX1

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem Failure of Implant (1924)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 22/jun/2021.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential events of "overstitch-difficulty passing anchor from exchange to needle body" as follows: note: ensure endcap is not dropped or otherwise damaged.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Warning: if sufficient slack has not been created prior to driving the anchor through tissue, retraction of the anchor exchange may be difficult and the anchor may not release correctly from the needle body.Anchor exchange will not install anchor onto the needle body: i.E.Ensure there is sufficient suture slack and the suture outside endoscope is not entangled.Ii.Ensure anchor exchange is properly positioned in alignment tube of needle driver.Iii.If anchor and suture are through tissue, either drop anchor and deploy cinch per section 9 of instructions for use or drop anchor and use a suitable accessory to cut and remove the suture.Iv.If anchor and suture are not through tissue, close handle of needle driver.Remove endoscope.Replace anchor and/or anchor exchange.

Event Description

Device malfunctioned and a competitor device was used.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): VIANT MEDICAL; 5079 33rd street se; grand rapids MI 49512
• Manufacturer (Section G): VIANT MEDICAL; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 12049856
• MDR Text Key: 257812760
• Report Number: 3006722112-2021-00054
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020718
• UDI-Public: (01)10811955020718(10)2020030354
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2020030354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR