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

Catalog Number 801403

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The customer called to report: there is a box of patties that contain an extra pattie with no string attached.Product code 80-1403, lot# 481293.(b)(6) 2014 the customer called and stated that there were no delays in surgery or adverse consequences to the patient.No patient information was provided and the product will be returned for an evaluation.(b)(6) 2014 the returned patty (with no string attached) was sent for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

The manufacturing lot traveler was pulled and reviewed for lot 481293.The product was produced in may of 2014.All information on the traveler indicates that the product was produced within specifications.There was an engineering change orders but it was for a gasket change on form fill seal which would be of a unrelated piece of equipment.All pull tests (which ensure proper bond between the string and pattie) were reviewed and found to be within acceptable limits.The minimum pull strength specification is 2.0 lb and this lot, but the alert level is 3 lbs.All the pull tests ranged from 3.4 lbs to 7 lbs.Therefore root cause could not be determined.It looks like the string wasn't presence when the welder came down to weld the components together.All the operators are trained to inspect all the patties and wrap them onto the card.It seems that the operator missed this reject and because there was ten patties with string the operator fulfilled the card requirement of having ten strings present, but with eleven patties.The machine always counts out 10 patties so the operator must of missed the first check pattie that the machine makes to start the process.The scenario above is a very rare occurrence.We have seen very few complaints for this particular failure mode.We will continue to monitor customer complaints to ensure this is not a developing trend which will require corrective action.At the present time this complaint is considered 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: 4011132
• MDR Text Key: 4959306
• Report Number: 1226348-2014-11898
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 801403
• Device Lot Number: 481293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• 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