MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURGICAL PATTIE, 1/2 X 1/2; SURGICAL SPONGE

Catalog Number 80-1400

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Call center transferred a call from dr.Indicating that he left 6 codman patties inside the patient.He cut them in half and left them in the diaphragm.He thought they were like the ethicon pledgit product.He wants to know what material they are made of and if they can be left in the patient.The rep contacted the dr.And provided specific information on pattie material and stated that to his knowledge the patties should not be left in the patient.It is unclear as to where the product was left (diaphram).

Manufacturer Narrative

Doctor left 6 codman patties inside the patient.The representative contacted the dr.And provided specific information (response to doctors request) on pattie material and stated that to his knowledge the patties should not be left in the patient.It is unclear as to where the product was left (diaphram).A review of the ifu for this product code indicates that the product should not be left in the patient.This complaint is associated with user unfamiliarity.The product remains implanted in the patient and it does not appear product will be returned to codman.At the present time this complaint is considered closed.No further action is required.

• Brand Name: SURGICAL PATTIE, 1/2 X 1/2
• Type of Device: SURGICAL SPONGE
• 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: 6504611
• MDR Text Key: 73217782
• Report Number: 1226348-2017-10271
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 80-1400
• Device Lot Number: H17229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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