MAUDE Adverse Event Report: ETHICON, INC. ETHICON SECURESTRAP; STAPLE, IMPLANTABLE

Catalog Number STRAP25

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/03/2016

Event Type  malfunction  

Event Description

Ethicon securestrap- 2 devices malfunctioned.One device fired numerous blank straps without device indicator turning orange (lot jlk983).Second device fired approximately 10 straps and the rest were blank - the indicator did turn orange after the approx.10 straps were fired (lot jlm634).

• Brand Name: ETHICON SECURESTRAP
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON, INC.; rout 22 west; somerville NJ 08876
• MDR Report Key: 5494557
• MDR Text Key: 40132823
• Report Number: 5494557
• Device Sequence Number: 1
• Product Code: GDW
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: STRAP25
• Device Lot Number: JLK983
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2016
• 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
• Patient Age: 47 YR
• Patient Weight: 101