MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number CNH-G01-000

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Premature Separation (4045)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to the apollo device analysis laboratory on 11/dec/2020.Analysis of the device is ongoing.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 "helix-did not turn properly" and "helix- could not be removed from tissue" as follows: "warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures." "caution: if resistance is encountered when advancing the helix through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly, and ensure that the secondary working channel is not obstructed on the endoscope." "caution: do not depress helix handle button while advancing helix through endoscope." "warnings: do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged." warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.

Event Description

The tissue helix got stuck in the tissue.The patient was treated successfully.

Manufacturer Narrative

Supplemental #1 medwatch submitted to the fda on 05/feb/2021.A discrepancy in our logging system was discovered on 02/feb/2021 in which the wrong complaint had been attached to the record.Corrections have been made and this complaint is no longer reportable as it was previously reported as mdr #: 3006722112-2020-00113.Corrections: b1, b3, b5, d4, h4, h6 additional info: h10.

Event Description

A cinch came loose from the suture prematurely, through which the seam couldn't be completed.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 11046350
• MDR Text Key: 222672297
• Report Number: 3006722112-2020-00129
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: 10811955020688
• 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
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF03701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 92