MAUDE Adverse Event Report: CODMAN SURGICAL PATTIE; PATTIE, COTTONOID

Catalog Number 24-5411

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the distributor, the strings were detaching from the surgical patties.There were no reports of delays or adverse consequences.

Manufacturer Narrative

Device was returned for evaluation.Upon completion of the investigation a followup report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the review of the device history records and product was done and no anomalies were found.This lot code appears to have met all testing requirement, there were no anomalies noted during manufacturing process.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 Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6794133
• MDR Text Key: 82686093
• Report Number: 1226348-2017-10597
• 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: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-5411
• Device Lot Number: HA3814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• 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