MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN 11MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Model Number 26-1222

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problems Hemorrhage/Bleeding (1888); Brain Injury (2219)

Event Date 04/22/2022

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 261222 ) failed to disengage; dura mater was torn, there was possible damage to cortex and bleeding was hard to stop.A cerebral contusion was visible on postoperative scan.Patient was asymptomatic.

Event Description

N/a.

Manufacturer Narrative

Dhr - there is no indication that the production process may have contributed to this complaint.Failure analysis - the perforator unit was inspected using the unaided eye.Unit was lightly soiled, no other anomalies noted.Ifu testing was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release; the unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: CODMAN 11MM DISPOSBL PERFORATR
• 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: 14414853
• MDR Text Key: 291809437
• Report Number: 3014334038-2022-00097
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10886704005117
• UDI-Public: 10886704005117
• Combination Product (y/n): N
• PMA/PMN Number: K071931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 26-1222
• Device Catalogue Number: 261222
• Device Lot Number: HD8964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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