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

Model Number CNH-G01-000

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Initial medwatch sent to the.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 "other reports-clinical outcome not device related" and "suture cinch-deployment difficulty" as follows: "warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures." "note: it is the collar that sets the final position of the cinch, not the plug." "caution: the safety spacer must only be removed immediately prior to deploying cinch." "troubleshooting: cinch does not cut the suture when fired: use a suitable accessory through the secondary working channel to cut the suture and remove the cinch." "use standard endoscopic techniques to remove the cut suture.".

Event Description

During the procedure several cinches would not fire properly and required additional sutures to complete the case.Patient presented pneumomediastinum, pneumoperitoneum, and subcutaneous emphysema.

Manufacturer Narrative

Supplement #1 medwatch sent to the fda on 27/aug/2020.The device was returned to the apollo device analysis laboratory on 06/aug/2020.Analysis of the device is ongoing.

Manufacturer Narrative

Supplement 1 medwatch submitted to the fda on 03/25/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6) 2020.Ccn0005551-1: a needle driver and anchor exchange was returned for evaluation.The needle driver is not actuated, and the needle body appears straight.Under microscopic analysis, there were no discrepancies with the needle body or any other components on the distal end of the needle driver.The endcap holder was installed on the endcap for testing and alignment pin was used.When the handle was depressed, the needle body tip entered the alignment pin hole without bending or flexing.The anchor exchange was returned with the blue button popped out of the housing.Unable to test the needle driver and anchor exchange together as the anchor exchange was returned damaged.It is likely that the anchor exchange button popped out when the catheter was coiled up as it was not reported by the customer.Ccn0005772-2: the cinch beaded wire was returned without the cinch plug, collar and suture material connected.The broken end of the beaded wire shows an angle and jagged edges where the wire was snapped.Based off the physical evidence of the returned device, the complaint was confirmed.Ccn0005772-3: the cinch beaded wire was returned without the cinch plug, collar and suture material connected.The broken end of the beaded wire shows an angle and jagged edges where the wire was snapped.Based off the physical evidence of the returned device, the complaint was confirmed.Ccn0005772-4: the cinch beaded wire was returned without the cinch plug, collar and suture material connected.The broken end of the beaded wire shows an angle and jagged edges where the wire was snapped.Based off the physical evidence of the returned device, the complaint was confirmed.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• MDR Report Key: 10317260
• MDR Text Key: 200435877
• Report Number: 3006722112-2020-00066
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020671
• UDI-Public: 10811955020671
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF03348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention