MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-160

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.Apollo has not received the product at this time.Therefore no analysis or testing has been done.A review of the device labeling notes the following: no risk review or complaints review for trends could be performed because there was not sufficient information to perform these activities.

Event Description

Consumer reported via email, "in our hospital we have a defective overstitch endoscopic suturing system with ref.Ess-g05-160 with lot number 2019011056 and expiration date 31-12-2021.Is it possible to credit this or send us a new one? the defect is in the pharmacy.Will this be picked up?" additional information noted, "ess did not work (needle driver malfunctioning).".

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 30/dec/2019.Device evaluation summary: a suture system with anchor exchange was received with no abnormalities visually observed during intake.The endcap holder was installed on the endcap for testing and alignment pin a2 was used.When the handle was depressed, the needle body tip entered the alignment pin hole without bending or flexing.The sample suture anchor was loaded into the anchor exchange, and the exchange was advanced into the endcap holder.When the needle driver was actuated, the anchor engaged to the needle body.This test was successfully repeated several times.No kinks or abnormalities were observed on the anchor exchange catheter and the heat shrink was not dislodged from the device.Under microscopic analysis, the inside of the receptacle was observed while pressing the release button.The reported overstitch suture cinch was not returned for evaluation.The reported overstitch suture was not returned for evaluation.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 19/dec/2019.The device was returned to the apollo device analysis laboratory on (b)(6) 2019.Analysis of the device is ongoing.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9447388
• MDR Text Key: 183977342
• Report Number: 3006722112-2019-00193
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• Combination Product (y/n): N
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2019011056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 90