MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID

Catalog Number 80-1404

Device Problems Material Discolored (1170); Component Missing (2306); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Upon completion of the investigation it was noted that the sample was received and reviewed. No sign of burn, mark, or stain. The reported " a surgical pattie was found to have a discolored stain" could not be verified. However; samples were observed to contain 11 patties instead of 10. The 11th pattie was missing string. The dhr/manufacturing lot traveler was pulled and reviewed for lot h27272. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. Therefore, root cause could not be determined. No corrective action will be taken at this time. 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.

Event Description

As reported by the ous affiliate, a surgical pattie was found to have a discolored stain / mark on it. Was not discovered during surgery, no patient was involved.

• Brand Name: CODMAN SURGICAL PATTIE
• Type of Device: PADDIE, 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: 7004580
• MDR Text Key: 92112167
• Report Number: 1226348-2017-10808
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K880402
• 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

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 80-1404
• Device Lot Number: H27272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/11/2017
• 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