MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problems Bruise/Contusion (1754); Dysphasia (2195); Brain Injury (2219)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a perforator (id 261221) failed to disengage.According to the surgeon, the consequences were: tearing of the dura mater; left upper temporal contusion with wound of a left temporal cortical artery, resulting on the mri at day 2 postoperatively in a constituted left temporo-parietal ischemia and clinically; language disorders of the mixed type of aphasia (the fluency disorders may be related to the left lower frontal approach for the removal of the sphenoidal meningioma, but not the jargonaphasia related to the ischemic lesion at a distance from the operative focus).The procedure was completed with a replacement product available.

Manufacturer Narrative

The perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications/did not pass procedural specifications.Failure analysis - visual inspection utilizing unaided eye.Unit was lightly soiled and had a worn eo label but no other anomalies were observed.Unit had a frozen inner / outer drill but was freed by cleaning organic material between the two parts then applying downward pressure on the tip of the inner drill.Once freed, unit passed the spring test as designed.Once freed, the unit successfully drilled 5 holes and functioned as designed therefore the complaint could not be verified by failure analysis.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15364356
• MDR Text Key: 299319646
• Report Number: 3014334038-2022-00195
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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