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

Model Number CHN-C01-213-L

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 12/may2/2023.A review of the device labeling notes the following: risk review verbiage less last including labeling and monitoring.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.Additional information: the investigator determined that a device history record (dhr) review was 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 were no other complaints in the apollo database against this lot number af05330 and allegation.

Event Description

Healthcare provider cinch suture broke during the cinching process.Procedure successfully completed with competitive device.Patient is doing well.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 27/jun/2023.Additional information: the investigator determined that a device history record (dhr) review was required for this complaint due to the complaint being vigilance or mdr reportable.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other complaints in the apollo database against this lot number af05330 and allegation.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 26/apr/2023.A cinch was returned dismantled.The suture was returned.Engineering visually inspected the device 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.As found condition for the detent height was not to specifications.The complaint has been verified as the detent did not secure the plunger.Lab analysis was able to replicate the reported event of "suture cinch-deployment difficulty", as the detent was out of specs.The user effect of "suture cinch-deployment difficulty" 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. 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: 16918417
• MDR Text Key: 315075996
• Report Number: 3006722112-2023-00082
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020756
• UDI-Public: (01)10811955020756(17)20251122(11)20221122(10)AF05330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CHN-C01-213-L
• Device Catalogue Number: CHN-C01-213-L
• Device Lot Number: AF05330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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 Age: 74 YR
• Patient Sex: Female