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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

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 the perforator did not stop and went through the dura.The procedure as completed with the same device without further issues.Damage to the dura was minimal.

Event Description

N/a.

Manufacturer Narrative

Udi - (b)(4).The perforator was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Perforator was received for evaluation: dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the perforator unit was inspected using the unaided eye.Unit was observed to be lightly soiled with organic matter, no additional anomalies observed.Instructions for use testing was performed with no observed anomalies.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.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.In conclusion, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• MDR Report Key: 11076585
• MDR Text Key: 223736902
• Report Number: 3014334038-2020-00127
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

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 Catalogue Number: 261221
• Device Lot Number: J8482K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/20/2021; 04/26/2021
• Supplement Dates FDA Received: 02/03/2021; 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1