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 No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the perforator failed to disengage during a craniotomy.The surgeon successfully made two burr holes and on the third burr hole the perforator did not disengage, ending with the perforator going through the dura.The patient has been following up and no harm has been observed.

Event Description

N/a.

Manufacturer Narrative

Device identifier: (b)(4).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

Additional information received: the patient has been scanned post operatively and no harm has been observed.No patient injury.Small delay while further equipment acquired.A further device was available.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d10, g1, g4, g7, h2, h3, h4, h6, h10.Udi - (b)(4).Perforator was returned for evaluation: dhr - all assembly process steps, cleaning, functional testing, labeling, packaging, and sterilization process steps were followed and completed with zero non-conformances.Failure analysis - the perforator unit was inspected using the unaided eye.No eto label and heavy organic matter present.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 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 02048
• MDR Report Key: 10381904
• MDR Text Key: 202969056
• Report Number: 3014334038-2020-00016
• 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,Followup
• Report Date: 07/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 261221
• Device Lot Number: J22W01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 08/21/2020; 01/06/2021
• Supplement Dates FDA Received: 08/28/2020; 09/10/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1