MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA SNAP CLAMP ASSEMBLY; SURGICAL RETRACTOR

Catalog Number 4040

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that on (b)(6) 2018, a 4040 snap clamp assembly part was missing during surgery.During a liver transplant procedure, it was noted that a part of the device was missing and it could not be determined if the part went inside the patient's abdomen.A query has been raised on what material of the pad is so it can be scanned and further medical intervention will follow.It is unknown if there was a delay in the procedure.The procedure was completed with the same like device.There were no adverse effect or injury on the patient noted at present.

Manufacturer Narrative

The device was not returned for evaluation.A dhr review cannot be performed at-this-time as the 3-digit lot code marked on the device was not provided nor has the product been sent in for inspection.Therefore, a failure analysis to identify the root cause to the end users experience could not be identified.The complaint reported was not confirmed.

Event Description

N/a.

• Brand Name: SNAP CLAMP ASSEMBLY
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8130813
• MDR Text Key: 129595979
• Report Number: 3004608878-2018-00275
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2018
• 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