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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problems Tissue Damage (2104); Brain Injury (2219)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Udi - (b)(4).It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a perforator failed to disengage, becoming stuck in the patient's brain.

Manufacturer Narrative

Additional event information has been provided.This report has been updated to reflect the updated information.

Event Description

Additional information received 06 july 2018: the event occurred (b)(6) 2018.To resolve the issue, the trephine was removed and haemostasis of the cerebral cortex.There was a cerebral contusion regarding the threphine hole.It was reported that there was language impairment in postoperative, but was probably linked to the tumor for which the female patient has been operated.

Manufacturer Narrative

Udi : (b)(4).Corrected field: device available for evaluation.It was previously reported that the device would be returned for evaluation.Multiple attempts to obtain the sample were not successful.This report has been updated with the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no anomalies when the device was released.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.

Manufacturer Narrative

Additional information: pma/510k, if follow-up, what type, device evaluated by mfr.The device was returned for evaluation.The perforator was visually inspected, no anomalies observed.Functional testing was then performed.A series of holes were drilled per the test method; no issues found.The device functioned as expected.A review of manufacturing records found the device conformed to specification when released to stock.Based on the results of the investigation, the reported issue could not be reproduced.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN DISPOSABLE PERFORATOR; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7655447
• MDR Text Key: 112910439
• Report Number: 1226348-2018-10482
• 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,Followup,Followup,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: HT5745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 02/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention