MAUDE Adverse Event Report: COVIDIEN LP ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Per staff report during a laparoscopic hiatal hernia repair and gastrectomy with sleeve placement, the endostitch device would not load the stitch.The device engaged when no stitch in place.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8711564
• MDR Text Key: 148426106
• Report Number: 8711564
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J9B2403EY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 110