MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 physician reported the perforator was stuck in the bone during a craniotomy.The perforator reportedly ¿could not come out from the bone after perforating.¿ therefore, bone around the drill was shaved to remove the drill and the procedure was completed.There was a 30-minute surgical delay.The manufacturer of the drill used with the perforator was anspach and the recommended spring tests were performed between each burr hole.

Manufacturer Narrative

The perforator was returned for evaluation.Unique device identification (udi) #: (b)(4).Failure analysis: the perforator unit was inspected using the unaided eye: a disassembled perforator with no "eto" label and heavy damage to outer drill and molded sleeve (non-manufacturing related) were observed.Unit was reassembled and re-sleeved prior to testing.Ifu testing procedure was performed with no observed anomalies functional testing was performed and 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.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10775970
• MDR Text Key: 214343566
• Report Number: 3014334038-2020-00078
• 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
• Report Date: 10/14/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1