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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Literature review no device return.Initial medwatch submitted to the fda on 27/may/2022.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 "other (migrated of suture)" as follows: warnings: do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged.Only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Contact of electrosurgical components with other components may result in injury to the patient and/or operator as well as damage to the device and/or endoscope.Verify compatibility of endoscopic instruments and accessories and ensure performance is not compromised.Note: refurbished scopes may no longer confirm to original specifications.Ensure that there is sufficient space for the needle to open.Ensure that the handle grip of the endoscopic suturing system is closed and locked during intubation and extubation.Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.Additional information: the device will not be returned for analysis, and since it is not possible to gather more information from the reporter, no additional information will be 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.

Event Description

From literature review: patient had a second esg performed due to feel of loss of satiety and during the endoscopy it was noted that several suteres migrated in the tissue.A laparoscpic roux-en-y gastric bypass was performed and patient is doing well after surgery.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: 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; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 14522117
• MDR Text Key: 295809818
• Report Number: 3006722112-2022-00047
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male