MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC. SURGICAL PATTIES; NEUROSURGICAL PADDIE

Catalog Number 80-1407

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2017

Event Type  malfunction  

Event Description

A patient presents to the or for a le fort 1 osteotomy.After initial incision near the gumline, cottonoids followed by gelfoam were packed into the patient's mouth to control bleeding.Once the gelfoam and cottonoids were saturated, they were removed often by pulling on the cottonoid identification string and handed to the surgical technician.New cottonoids and gelfoam were then added.During removal of a set of foam and cottonoids, the surgical technician notified the team that they had received a string containing fibers at one end, but no cottonoid attached.The surgeon performed a brief search for the missing cottonoid, then opted to continue the case with the plan to get an x-ray to look for the cottonoid.The cottonoid was missed on x-ray, and the patient was returned to the or two days later to retrieve the retained cottonoid.General concern: the design of the "identification string" predisposes clinicians to misusing the string as a means to remove the cottonoid, which could result in breaking of the string or shearing of the cottonoid when being removed from the patient.

• Brand Name: SURGICAL PATTIES
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7181680
• MDR Text Key: 96972035
• Report Number: 7181680
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 80-1407
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other