MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/4X1/4-200; SURGICAL PATTIES

Catalog Number 801399

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that while patties were being used to clean away lasered tissue in the patients larynx, threads were coming loose from the patties and sticking to the patients good tissue.Another packet was accessed for use and the same occurred.Threads had to be picked off so not to potentially cause residual infection for the patient post operatively, due to foreign body present.

Event Description

N/a.

Manufacturer Narrative

Udi (b)(4).The complaint sample was not returned to codman, therefore, an evaluation of the device could not be performed.Device history records (dhrs) were reviewed and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.

Manufacturer Narrative

Udi information (b)(4).The product was not returned for evaluation, however a review of the photos was utilized.A review of manufacturing records was performed and the device was found to have conformed to specification when released.This product is a neurosurgical sponge (¿pattie¿) which are intended to be moistened and placed on brain (and other central nervous system) tissue to keep the keep it moist/protect it.This appears to be a case of misuse, since as the ifu indicates, these delicate patties are not intended for use in ¿clearing away tissue¿ in the larynx.The string becoming loose/stuck would be a symptom of the seeming misuse.The sponges in the provided photos appear to have been normal product, and nothing about their appearance suggests any material nonconformance.

Event Description

N/a.

• Brand Name: SURG PATXRAY 1/4X1/4-200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8922366
• MDR Text Key: 155273260
• Report Number: 1226348-2019-00355
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 801399
• Device Lot Number: HR2768
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1