MAUDE Adverse Event Report: INCISIVE SURGICAL, INC INSORB SKIN STAPLER

Lot Number 155191

Device Problem Failure to Deliver (2338)

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

Event Date 03/15/2016

Event Type  malfunction  

Event Description

Insorb stapler miss-fired, then the staples wouldn't come out.New stapler opened and used without incident.Manufacturer response for subcuticular skin stapler, insorb subcuticular skin stapler (per site reporter): material management will contact sales rep to arrange return if desired by their company.

• Brand Name: INSORB SKIN STAPLER
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): INCISIVE SURGICAL, INC; 14405 21th ave. n suite 130; plymouth MN 55447
• MDR Report Key: 5528714
• MDR Text Key: 41233169
• Report Number: 5528714
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2017
• Device Lot Number: 155191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 44 YR
• Patient Weight: 85