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

Catalog Number 24-5411

Device Problem Material Frayed (1262)

Patient Problem No Information (3190)

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 medline, a customer received codman neuro sponges that were frayed around the edges.Event did not occur intraoperatively, cause any delays or adverse consequences.Another package was taken from the shelf to replace.

Manufacturer Narrative

It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the lot number was not provided so traveler documentation could not be reviewed.Visual inspection confirmed visual fraying on pattie edges.This product is documented in the ifu as low linting.While there is variation inherent in our manufacturing process of the cottonoid material, our objective is to produce product with the least possible amount of linting.Therefore lot to lot variation in the cottonoid process may result in lots that lint more or less than the norm."linting" can also come from the quality of the edge cut from the slitting process, but the parts received did not show that issue.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: PATTIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6866529
• MDR Text Key: 86271177
• Report Number: 1226348-2017-10679
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-5411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• 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