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

Model Number 2030

Device Problem Crack (1135)

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

Event Date 01/25/2016

Event Type  malfunction  

Event Description

Surgeon went to use device and tip of device cracked while using.This happened a week prior on another case.In both instances a new insorb was opened and used.

• Brand Name: INSORB SUBCUTICULAR SKIN STAPLER
• Type of Device: SURGICAL STAPLER
• Manufacturer (Section D): INCISIVE SURGICAL, INC.; 14405 21st avenue north; plymouth MN 55447
• MDR Report Key: 5503464
• MDR Text Key: 40489327
• Report Number: 5503464
• Device Sequence Number: 0
• Product Code: GAG
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/01/2017
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 154301
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.