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

Model Number 230-261

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Rongeur from laparoscopic-ultra minilaparotomy myomectomy (lum) laparoscopically assisted myomectomy (lam) broke while in use.Surgeon removed the broken piece and the rongeur.Nurse removed both pieces from surgical field.X-ray notified.X-ray taken to rule out any retained pieces.Radiologist confirmed no retained fragments.

• Brand Name: INTEGRA JARIT
• Type of Device: RONGEUR
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 11594741
• MDR Text Key: 243148111
• Report Number: 11594741
• Device Sequence Number: 1
• Product Code: HTX
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 230-261
• Device Catalogue Number: 230261
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA