MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA JARIT; PROBE, LACHRYMAL

Model Number 360-280

Device Problems Break (1069); Disconnection (1171)

Patient Problem Inflammation (1932)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

Narrative from staff: a lacrimal probe broke into two pieces during surgery.Both pieces were retrieved and saved.Narrative from op report: the inflamed fistula was followed across the base of the nipple with the lacrimal probe serving as a guide.There was no communication to the central as they exited the tip of the nipple.During retraction for the dissection, the wire portion of the probe became disconnected from its hub.The tract was removed with the wire portion of the probe.The tissue was sent fresh for immediate pathologic processing.The defect was then palpated and inspected.

• Brand Name: INTEGRA JARIT
• Type of Device: PROBE, LACHRYMAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd; mansfield MA 02048
• MDR Report Key: 12696871
• MDR Text Key: 278341826
• Report Number: 12696871
• Device Sequence Number: 1
• Product Code: HNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/20/2021

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: Health Professional
• Device Model Number: 360-280
• Device Catalogue Number: 360280
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Weight: 81