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

Catalog Number 80-1404

Device Problems Defective Component (2292); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

User reported that there were 11 patties in a pack and the extra patty was found without string (there should be 10 patties in one pack).

Manufacturer Narrative

(b)(4).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.Root cause is likely due to operator error, this however could not be determined.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 #.Most likely the machine was interrupted in the middle of the cycle.This would cause the machine to stop immediately.This would most likely be the root cause on how a pattie without string was created.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: 5346585
• MDR Text Key: 35165137
• Report Number: 1226348-2016-10017
• 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: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1404
• Device Lot Number: 676558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• 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