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

Catalog Number 80-1408

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Eleven (11) neuro patties found in the package.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the corrective action was to check the manufacturing documentation for this lot and perform a tcr for all the operators associated with the lot under question.The manufacturing documentation for lot was pulled and reviewed.Nothing was found to be out of the ordinary with this work order.Root cause is likely due to operator error; this however could not be confirmed.Per the requirements of the specification the operator is required to inspect the front and back of the patties and also count the amount of surgical patties.Operators are trained to wrap each string onto a counting card to make it very visible and to confirm that there are only 10 surgical patties on the card.A tr was opened to retrain all the operators that had worked on this product and lot #.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.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: 6069120
• MDR Text Key: 58844984
• Report Number: 1226348-2016-10769
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1408
• Device Lot Number: C02900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• 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
• Patient Outcome(s): Required Intervention