MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1X3; PATTIE, COTTONOID

Catalog Number 80-1408

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation a follow up report will be filed.

Event Description

Before opening the package, brown spots were found on the surface of the product.There were no adverse consequences associated with this event.

Manufacturer Narrative

Device evaluation: upon completion of the investigation it was noted that the manufacturing documentation was reviewed for any variations in current process and no variations were found.A light brown 'spot' (under 0125" in diameter) was on the top pattie in the pack, directly around/below the area of the green string.The spot was produced when the string was welded to the cottonoid material.The cottonoid is formed from a rayon material.During processing this rayon material is broken down into small, loose fibers.If the fibers do not break down enough, a small cluster of fibers can result.This in turn creates a thick spot in the pattie.When the string is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.We use an automated machine to produce this product code.The patties are inspected by a computer vision inspection system that inspects the patties for defects.The burn marks are difficult to detect due to the type of color filters used on the camera lens.This sample under question was tested under the cameras on our automated pattie machine and the marking was not able to be detected by the camera system.The marking was found to be too faint to be detected my the system.Since the marking is from burnt rayon material, it would not affect the patient during surgery.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: SURG PAT XRAY 1X3
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5367587
• MDR Text Key: 36349075
• Report Number: 1226348-2016-10057
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1408
• Device Lot Number: 628594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1