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

Model Number ESS-G02-160

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.Uf/importer report #: (b)(4).A risk review could not be conducted as there is insufficient information regarding the event.

Event Description

Reported as: "during case, the apollo overstitch endoscopic suturing system device failed, preventing the surgical case from being completed.".

• 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
• 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: 9974975
• MDR Text Key: 191008096
• Report Number: 3006722112-2020-00052
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• 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,health
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/02/2020
• 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 Age: 46 YR
• Patient Weight: 153