MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number CB12LT

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

It was reported that there was foreign debris in the sealed packaging of the trocar.The issue was noticed in inventory, and the device was not used on a patient.

Manufacturer Narrative

A supplemental will be submitted once device evaluation is complete.

Manufacturer Narrative

The device was received sealed in the original tyvek pouch.Visual inspection of the returned complaint device revealed multiple small pieces of contaminant inside the enclosed pouch.The returned complaint device was submitted to an independent lab for material characterization using fourier transform infrared (ftir) spectroscopy and submitted for protein and hemoglobin extraction.Protein results concluded that the device had protein levels that met the acceptable allowable limit from tir 30.Hemoglobin results also met the acceptable allowable limits of tir 30 and concluded that there were non-detectable amounts of hemoglobin present on the device.Based on the results of the investigation it can be concluded that the initial report does not meet the criteria for a reportable malfunction but a report was filed in order to meet the 30 day reporting requirement while the investigation was being conducted.The most likely root causes of the reported event included contamination during inspection and packaging of the device, operator oversight of debris during inspection, or migration of dislodged debris post-sterilization.Action is being taken to address this issue and the reported event will continue to be monitored through post market surveillance.

Event Description

It was reported that there was foreign debris in the sealed packaging of the trocar.The issue was noticed in inventory, and the device was not used on a patient.

• Brand Name: NA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 4812073
• MDR Text Key: 5836288
• Report Number: 0001056128-2015-00041
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

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 Expiration Date: 11/30/2017
• Device Model Number: CB12LT
• Device Catalogue Number: CB12LTRR
• Device Lot Number: 3397633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1