MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-160

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

Patient Problems Fever (1858); Unspecified Infection (1930); Necrosis (1971); Sepsis (2067)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system directions for use (dfu) addresses the known and anticipated potential event of "clinical outcome not device related" as follows: warnings: verify compatibility of endoscope size, endoscopic instruments and accessories and ensure performance is not compromised.Use of the system is only recommended when accompanied by an overtube.Verify compatibility of device with overtube prior to use.Only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: infection/sepsis.

Event Description

Patient hospitalized for fever and sepsis after an anastomosis reduction.Not device related - infection acquired at the hospital.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 24/nov/2020.The reporter noted that the device will not be returned for analysis.The reported also mentioned that the patient is stable and will need a cancellation surgery.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 10586675
• MDR Text Key: 208545835
• Report Number: 3006722112-2020-00085
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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
• Device Lot Number: 2519
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR