MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC; STAPLER

Model Number 35

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/22/2017

Event Type  malfunction  

Event Description

Doctor noticed the staplers were not approximating appropriately.

• Type of Device: STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek road; ml 120a; cincinnatti OH 45242
• MDR Report Key: 7024277
• MDR Text Key: 91780409
• Report Number: 7024277
• Device Sequence Number: 1
• Product Code: GAG
• 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: Other
• Type of Report: Initial
• Report Date: 10/22/2017,10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 35
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 62 YR