MAUDE Adverse Event Report: INTEGRA YORK, PA INC. PUNCTURE NEEDLE W/IRRIG 32CM; SUCTION/IRRIGATION

Catalog Number 600490

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed the labeling, material, and process controls were within specification.

Event Description

An integra territory manager reported that on (b)(6) 2017, the needle tip portion of the puncture needle with irrigation bent 90 degrees when trying to insert it into the gallbladder by the surgeon during a laparoscopic cholecystectomy.Upon removing the instrument from the patient, the needle tip portion broke off completely and fell onto the floor.There was no patient injury or complications noted.However, there was a delay in surgery since the clinical team was trying to search for the broken tip.

• Brand Name: PUNCTURE NEEDLE W/IRRIG 32CM
• Type of Device: SUCTION/IRRIGATION
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7173927
• MDR Text Key: 97728112
• Report Number: 2523190-2017-00164
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K120012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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