MAUDE Adverse Event Report: INCISIVE SURGICAL INC. INSORB SUBCUTICULAR SKIN STAPLER

Lot Number 162701

Device Problems Defective Component (2292); Failure to Form Staple (2579); Activation, Positioning or Separation Problem (2906)

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

Event Date 12/12/2016

Event Type  malfunction  

Event Description

According to the scrub tech the insorb stapler was working on one side of the staple gun only which prevented it from deploying the staples correctly as the other side of the gun was not working.The defective equipment was changed out to another stapler for the rest of the c-section case.

• Brand Name: INSORB SUBCUTICULAR SKIN STAPLER
• Type of Device: STAPLER
• Manufacturer (Section D): INCISIVE SURGICAL INC. ; plymouth MN 55447
• MDR Report Key: 6193329
• MDR Text Key: 63103283
• Report Number: MW5066822
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Lot Number: 162701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 97