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

Catalog Number 80-1408

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

Udi -- (b)(4).It has been reported that the device will not be returned for evaluation.A photo of the device and a lot number have been provided.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported by an affiliate that the surg pat xray 1x3 appeared to be contaminated despite the package being intact.There was no reports of surgical delays or patient harm.The sample will not be returned but a photo has been taken.

Manufacturer Narrative

Udi: (b)(4).Applicable device history record (dhr)s were reviewed and no discrepancies were found.The sample was not returned thus evaluation is being completed based on provided photo.Pattie was reported to have a large brown contamination on the pattie despite still being sealed.This brown spot is consistent with a pattie burn.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 are not broken down properly, a small cluster of fibers will result causing 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 resulting in a burn.Automated machines are used 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.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: SURG PAT XRAY 1X3
• Type of Device: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7970565
• MDR Text Key: 123965028
• Report Number: 1226348-2018-10724
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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: HU3679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1