MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA JARIT; FORCEPS

Model Number 109-102

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/06/2021

Event Type  malfunction  

Event Description

Surgical patient's skin punctured by towel clips.This was discovered by the certified surgical technician at the end of the case when undraping the patient.The surgeon and physician assistant had left the operating room.Monitoring for unnecessary pain and infection.

• Brand Name: INTEGRA JARIT
• Type of Device: FORCEPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 11235709
• MDR Text Key: 228875525
• Report Number: 11235709
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: 109-102
• Device Catalogue Number: 109102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6935 DA
• Patient Weight: 85