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

Model Number ESS-G02-160

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Fever (1858)

Event Date 02/09/2020

Event Type  Injury  

Manufacturer Narrative

Initial medwatch sent to the fda.The device will not be returned for analysis, hence, analysis of the device is not possible.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-clinical outcome device related" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.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.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: pharyngeal, colonic and/or esophageal perforation esophageal, colonic and/or pharyngeal laceration intra-abdominal (hollow or solid) visceral injury the labeling is adequate as it addresses the reported complaints.The occurrence of this reported complaint for this product will be reviewed as appropriate in the complaints analysis meeting (cam).

Event Description

Reported as: patient presented fever 3.5 weeks after esg procedure.Patient was diagnosed with liver abscess and was hospitalized and treated with antibiotics.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM (ESS)
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• Manufacturer (Section G): VIANT MEDICAL; 5079 33rd street se; grand rapids, mi
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• MDR Report Key: 9808744
• MDR Text Key: 183975768
• Report Number: 3006722112-2020-00046
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2019091049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• 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): Hospitalization
• Patient Age: 43 YR