MAUDE Adverse Event Report: AMERICAN SURGICAL COMPANY RAY-COT; NEUROSURGICAL SPONGE

Catalog Number 60-06

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

A review of manufacturing records found no discrepancies.The customer was unable to provide the exact lot number for the device.There records show three lot numbers on hand.The complaint device was used and is unable to be tested, however, reference samples retained by asc were tested from the three lot numbers provided by the customer.All samples tested met acceptance criteria.On (b)(6) 2020 unused devices were returned to asc by the customer.Samples from the returned devices were also tested.All samples tested met acceptance criteria.At this time we consider this complaint to be closed.

Event Description

It was reported that during surgery, the identification thread detached from the surgical sponge.There was no reports of delay or patient harm.

• Brand Name: RAY-COT
• Type of Device: NEUROSURGICAL SPONGE
• Manufacturer (Section D): AMERICAN SURGICAL COMPANY; 45 congress street; suite 153; salem MA 01970
• Manufacturer (Section G): AMERICAN SURGICAL COMPANY; 45 congress street; suite 153; salem MA 01970
• Manufacturer Contact: sasha sylvia ; 45 congress street; suite 153; salem, MA 01970 ; 7815927200
• MDR Report Key: 9734934
• MDR Text Key: 193403476
• Report Number: 1221144-2019-00001
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-06
• Device Lot Number: LOT NUMBER UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention