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

Model Number	26-1222
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Brain Injury (2219)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
N/a.
Additional 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
• Common Device Name: 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
• Report Number: 3014334038-2022-00097
• Device Sequence Number: 12131063
• Product Code: HBF
• UDI-Device Identifier: 10886704005117
• UDI-Public: 10886704005117
• Combination Product (Y/N): N
• PMA/510(K) Number: K071931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown