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

Model Number ESS-G02-160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762)

Event Date 09/12/2022

Event Type  Death  

Manufacturer Narrative

Initial medwatch submitted to the fda on 13/jan/2023.A review of the device labeling notes the following: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.The current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "suture assembly - suture broke during procedure" as follows: the system may only be used if purchased from apollo endosurgery, inc.Or one of its authorized agents.With the endoscopic suturing system installed, the endoscope's primary channel effectively becomes a 3.2 mm channel.An overtube with an internal diameter of at least 16.7 mm may be used with the system to protect the esophagus.The overstitch is compatible with the following endoscopes: olympus 2t160, 2th180, or 2t240 fuji ei-740d/s adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: ·pharyngitis / sore throat ·nausea and / or vomiting ·abdominal pain and / or bloating ·hemorrhage.·hematoma.·conversion to laparoscopic or open procedure.·stricture.·infection / sepsis.·pharyngeal, colonic and/or esophageal perforation.·esophageal, colonic and/or pharyngeal laceration.·intra-abdominal (hollow or solid) visceral injury ·aspiration.·wound dehiscence.·acute inflammatory tissue reaction.·death.Note: any serious incident that has occurred in relation to the device should be reported to apollo endosurgery (see contact information at the end of this document) and any appropriate government entity.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.

Event Description

After the gen 2 surgery, the patient started bloating and vitals signs dropped.The patient was moved to icu to stabilized.The patient passed away a short while later.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 27/mar/2023.Additional information: the device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.Autopsy was requested but have not received report.If one is received the report will be updated.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM
• Type of Device: SUTURING SYSTEM F
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin TX 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, TX 78746 ; 5122795114
• MDR Report Key: 16158738
• MDR Text Key: 308751921
• Report Number: 3006722112-2022-00138
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: (01)10811955020664
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 100 KG