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

Model Number CNH-G01-000

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Healthcare professional reported the cinch handle cable is broken as the cinch wire snapped, two suture threads have come loose from the anchor and a two other sutures detached from anchor.Surgery extended by at least 30 minuets.Patient is doing well.

Manufacturer Narrative

Combined medwatch submitted to the fda on 20/sep/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 cinch deployment difficulty as follows: 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.The current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of suture broke during procedure as follows: warning: do not introduce the device with the needle body in its open position.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.Anchor exchange will not install anchor onto the needle body: i.Ensure there is sufficient suture slack, and the suture outside endoscope is not entangled.Ii.Ensure anchor exchange is properly positioned in alignment tube of needle driver.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.Ensure that there is sufficient space for the needle to open.The current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of broke / damaged / defective component as follows: "warnings: do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged." additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against these lot number, af05233, and allegation,af05233.Device evaluation summary: the devices were returned to the apollo device analysis laboratory on 17/july/2023.A cinch, ensizor scissors and eight (8) new sutures in sealed packaging were returned for evaluation.The cinch was returned dismantled.Engineering visually inspected the cinch and found; the plunger was dislodged from the cinch housing which intern cut the suture while shuttling forward.The housing detent did not secure the plunger in place, and this is why the plunger dislodged.There were three (3) sutures removed from their sealed packaging for functional testing.An anchor/suture force test was conducted and found two (2) out of the three (3) sutures did not meet the minimum force retention requirement.Engineering then visually inspected the returned ensizor scissors and found the wire was pulled out.It was reported that the scissors were used to cut wire; however, the scissors are not intended to cut wire.The complaint has been verified as the returned devices showed signs of failure.The user effects of "suture cinch-deployment difficulty" is a known and labeled possible adverse event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Type of Device: SUTURE SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 17782992
• MDR Text Key: 323858958
• Report Number: 3006722112-2023-00195
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF05233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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: Female