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

Catalog Number 80-1403

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

Patient Problem No Information (3190)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the ous affiliate, in a 10-pk of surgical patties, 11 were found.The extra pattie lacked the radio opague string.New product was used to complete the procedure.There were no delays or adverse consequences reported.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that after the task of replenishing cottonoid, x-ray monofilament, green string or any maintenance work, the machine will produce one pattie.The reason it does this is to prime the line with material and for the operator to review the part being made.This first part is scrapped by the operator and the machine is ready to start making stacks of 10.The only time a stack can have more than 10 is in this situation when the operator doesn¿t remove that first piece.The only time the machine can make a piece without the green string or blue monofilament is at this time.The operator has been informed and retrained about this issue.The hybrid machines are designed only to produce a stack of 10 patties at a time.The only time it will not produce a stack of 10 patties is right at the beginning when the machine will produce 1 pattie to verify the machine is operating properly and if the machine is interrupted in the middle of a cycle.Operators are trained to discard all stacks that are interrupted and any patties produced at the startup of the machine.A tcr and ilc were opened to retrain the operators that produced this lot in question.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: 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: 6906964
• MDR Text Key: 87886245
• Report Number: 1226348-2017-10721
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1403
• Device Lot Number: HS2044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2017
• 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
• Patient Sequence Number: 1