MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number ESS-G02-160

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Tissue Damage (2104)

Event Date 10/08/2019

Event Type  malfunction  

Event Description

During the sixth suture, the cinch caught on the needle anchor and the end cap was dislodged from the endoscope tip and caught on gastric tissue on the right posterior wall at the site of the pouch reduction.Multiple attempts were made to remove the end cap from the stomach using argon plasma coagulation (apc), as well as needle knife.The gastric tissue caught in the end cap device was successfully separated from the end cap with use of needle knife and removed from the patient.Abdomen was firm and distended.Patient was taken to ct-scan stat for chest/pelvic and abdomen x-rays.No free air seen on imaging.The device got "sutured" into the stomach of a patient with roux-y gastric bypass.Physician had to cut out the device with a needle knife.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 9327504
• MDR Text Key: 166557130
• Report Number: 9327504
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2019060942
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23725 DA
• Patient Weight: 110