MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number	THX-165-028
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the apollo device analysis laboratory on 03/nov/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 or Problem Description
The tissue helix got stuck in the tissue.The patient was treated successfully as a back-up device was used to complete the case.
Additional Manufacturer Narrative
Supplement #1 submitted on 04/mar/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 03/nov/2020.One tissue helix was returned with blood/tissue present inside the sheath.The knob was pushed down, and it extended the coil as intended, then the knob was pulled up and the coil retracted into the catheter as intended.During rotation of the knob, the turning knob would stick and become intermittent on rotation.Under microscopic analysis, the helix tip appeared to be sharp.The complaint was verified as functional evaluation showed the rotation knob was difficult to turn.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Common Device Name: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 11046152
• Report Number: 3006722112-2020-00125
• Device Sequence Number: 11024793
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: 10811955020688
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K081853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF03608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention