MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD IRIS SCS 4-1/2 CVD TC; M5 - GENERAL SURGERY

Model Number 5-306TC

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the iris curved scissor (5-306tc) malfunctioned during surgical excision.The device snapped and a metallic piece was found within the deficit.It was reported that there was a 2-hour surgical delay in the procedure.No patient injury or death occurred.

Manufacturer Narrative

Despite several attempts to obtain the product, the curved iris scissor (5-306tc) was not returned; therefore, an evaluation of the device could not be performed.A definitive root cause of the malfunction reported by the customer could not be determined.The issue of device snapped may be the result of rough handling/environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated b5: it was subsequently reported that the two-hour surgical delay was because after the device snapped, both physician and surgical staff had to ensure there were no remnants of the instrument left before any further surgical procedure was continued and before the provider sutured the excision site closed.The surgical tech had to glove out of the sterile procedure to go get an instrument similar to what was used for the type of procedure being done.The procedure was completed.It was also reported that the broken piece was big enough to be seen on the top of the skin and the entire broken piece was removed from the surgical site.

• Brand Name: IRIS SCS 4-1/2 CVD TC
• Type of Device: M5 - GENERAL SURGERY
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13584494
• MDR Text Key: 289531652
• Report Number: 3014334038-2022-00028
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 10381780437277
• UDI-Public: 10381780437277
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5-306TC
• Device Catalogue Number: 5-306TC
• Device Lot Number: AA2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/11/2022; 05/03/2022
• Supplement Dates FDA Received: 03/12/2022; 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1