MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES, & ACC.

Catalog Number 26-1221

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/24/2014

Event Type  Injury  

Event Description

Customer's purchasing department called and informed that: "surgeon reported that a portion of a codman disposable perforator label fell inside the patient's wound during surgery.The piece of label was promptly removed from the wound without any adverse consequences to the patient.Surgery was not delayed for more than 30 minutes.No patient's information available.(b)(4).

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The customer's complaint (a portion of the label fell inside the patients wound during surgery)was not verified.This evaluation confirmed that an area of the label was torn away; leaving frayed paper, and evidence of the label's adhesive backing.A review of the eto label's receiving records show the label's used on this perforator lot passed all inspection requirements, including a functional test for adhesive.The device history records for this perforator were reviewed.All tests and inspections associated with the assembly process, met specification requirements.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES, & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedfird MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3765224
• MDR Text Key: 4469307
• Report Number: 1226348-2014-11420
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: AG015S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2014
• 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
• Patient Outcome(s): Required Intervention