MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISP PERFORATOR; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 26-1222

Device Problem Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was not returned to codman and no product or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Event Description

It was reported that the auto release on the perforator did not work.There was no reported patient injury.The complaint device was replaced with another perforator.No further information was provided by the hospital.

Manufacturer Narrative

The device was received for evaluation.The perforator was visually inspected, and the product label was slightly worn.The perforator was then functionally tested.A series of holes with drilled without issues.The device performed as intended.A review of manufacturing records could not be performed as no lot number was provided.Based on the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISP PERFORATOR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8340255
• MDR Text Key: 136608634
• Report Number: 1226348-2019-10100
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1