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

Model Number ESS-G02-160

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 02/jun/2023.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 event of "suture assembly-suture broke during procedure" and overstitch suture cut/broke during exchange as follows: 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: ensure appropriate suture slack has been created for desired suture path and pattern.Advance anchor exchange and/or manipulate endoscope to create suture slack.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Note: ensure suture is not tangled after removal from the cartridge.Caution: do not use when valve covers are closed as suture drag will be increased.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.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint as the complaint is an mdr.There are no other complaints against this lot number, af05080, and allegation.Device evaluation summary: the devices were returned to the apollo device analysis laboratory on 08/may/2023.A needle driver and anchor exchange were returned for evaluation.Under microscopic analysis, the needle body is straight.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.A 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.The anchor exchange release button was within the appropriate travel distance of the release handle.Under microscopic analysis, the inside of the receptacle was observed while pressing the release button.The latch, hard stop, and opener were all observed; the opener passed under the latch while advancing towards the distal end of the receptacle.The sample suture anchor was inserted into the receptacle for testing; when the release button was pressed, the anchor released.A v magnetic block was put inside the vice grip block and tightened to secure.The alignment tube was placed on the v block, one end of the suture was fed through the alignment tubing and secured to a weight.The suture was pulled up and down approximately ten times and the suture did not break.The complaint could not be verified as the suture did not break during testing.Lab analysis was not able to replicate the reported event of "overstitch-suture broke/ cut during exchange".It has not been possible to determine a root cause for this reported complaint.The user effect of "overstitch-suture broke/ cut during exchange" is known and labeled possible adverse event.

Event Description

The suture became detached from the needle several times during the procedure.A backup device was used to partially complete the procedure.Another surgery may be scheduled to fully complete the original procedure.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 13/jul/2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint as the complaint is an mdr and found the subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number, af05080, and allegation.Device evaluation summary: the devices were returned to the apollo device analysis laboratory on 08/may/2023.A needle driver and anchor exchange were returned for evaluation.Under microscopic analysis, the needle body is straight.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.A 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.The anchor exchange release button was within the appropriate travel distance of the release handle.Under microscopic analysis, the inside of the receptacle was observed while pressing the release button.The latch, hard stop, and opener were all observed; the opener passed under the latch while advancing towards the distal end of the receptacle.The sample suture anchor was inserted into the receptacle for testing; when the release button was pressed, the anchor released.A v magnetic block was put inside the vice grip block and tightened to secure.The alignment tube was placed on the v block, one end of the suture was fed through the alignment tubing and secured to a weight.The suture was pulled up and down approximately ten times and the suture did not break.The complaint could not be verified as the suture did not break during testing.Lab analysis was not able to replicate the reported event of "overstitch-suture broke/ cut during exchange".It has not been possible to determine a root cause for this reported complaint.The user effect of "overstitch-suture broke/ cut during exchange" is known and labeled possible adverse event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 17063495
• MDR Text Key: 316609414
• Report Number: 3006722112-2023-00110
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: (01)10811955020664(17)20250731(11)20220731(10)2022080924
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2022080924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2022
• 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 Sex: Male