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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 06/18/2020

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 failed to disengage causing dura matter injury while performing the first and second burr-hole during a craniotomy.The injury was treated with hemostasis and suture and the procedure was completed with a replacement product.The product problem caused a 30 minutes surgical delay with no patient consequences.

Event Description

N/a.

Manufacturer Narrative

(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

Unique device identifier (udi)- (b)(4).The perforator was returned for evaluation: device history record (dhr)- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis- perforator was visually inspected, organic matter was present.Functional testing, found to perform as intended.Complaint could not be verified.The perforator was found to meet all acceptance criteria / tested within the specifications.The root cause of the reported incident is undetermined, as the reported complaint was unable to be confirmed in the complaint evaluation.The returned perforator tested within specifications.

• 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: 10261435
• MDR Text Key: 198528310
• Report Number: 1226348-2020-00386
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: J6712D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1