MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOSCOPIC CURVED INTRALUMINAL STAPLER; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Catalog Number ECS29A

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 02/07/2011

Event Type  malfunction  

Event Description

Stapler fired but did not seal tissue/leak.Manufacturer response for endoscopic curved intraluminal stapler, (brand not provided) (per site reporter): pending.

• Brand Name: ENDOSCOPIC CURVED INTRALUMINAL STAPLER
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 6857942
• MDR Text Key: 85803179
• Report Number: 6857942
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: ECS29A
• Device Lot Number: N92365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR