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

Model Number ECS25A

Device Problem Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 04/23/2019

Event Type  malfunction  

Event Description

A patient was re-admitted for an open laparotomy with bowel resection and colostomy.It was discovered upon chart review that a recall occurred almost two weeks earlier for a series of staplers.One of these staplers was used the next day during a surgical bowel resection.It is unclear whether stapler failure caused or contributed to the need for a revision surgery.

• Brand Name: ETHICON CIRCULAR STAPLER
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 8775531
• MDR Text Key: 150566256
• Report Number: 8775531
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20705036003493
• UDI-Public: (01)20705036003493
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECS25A
• Device Catalogue Number: ECS25A
• 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: 06/04/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• 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: 26280 DA
• Patient Weight: 77