MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2 X 3; PATTIE, COTTONOID

Catalog Number 80-1407

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the ous affiliate, during surgery, the surgeon noticed a metal splinter on the surgical pattie.The pattie was set aside, and no delays were reported.

Manufacturer Narrative

Upon completion of the investigation it was noted that the sample pattie that was sent back for evaluation was tested on the automated pattie machine camera system and it was rejected every time.The sample was also shown to the operators for evaluation.The sample must have had the metal added to it sometime later in the process.We will continue to monitor customer complaints to ensure this is not a developing trend which will require corrective action.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.

Manufacturer Narrative

Manufacturing documentation was reviewed for any variations in current process and no variations were found.Lot number was sent in with the sample (lot number 702890).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 1/2 X 3
• 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: 6380393
• MDR Text Key: 69169141
• Report Number: 1226348-2017-10141
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1407
• Device Lot Number: 702890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided; 11/07/2017
• Supplement Dates FDA Received: 05/24/2017; 11/08/2017
• 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