MAUDE Adverse Event Report: RAYNHAM 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 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 that the perforator did not stop as it was supposed to and got stuck in the patient¿s skull during a craniotomy case.The physician had to use a drill to get the perforator out of the patient¿s skull.An anspach pneumatic drill was used with the perforator.A surgical delay was noted, unknown for how long.No patient injury reported.

Manufacturer Narrative

Device identifier #: (b)(4).The perforator was returned for evaluation.Device history record - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - visually inspected utilizing unaided eye.Units have not been used.No manufacturing defects present.Results of instruction for use (ifu) testing procedure and results of functional test performed, all unit was found to perform as intended.The root cause is undetermined and the reported complaint was unable to be confirmed in the complaint evaluation.The returned perforator tested within specifications.

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: 10326867
• MDR Text Key: 202032608
• Report Number: 3014334038-2020-00002
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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 Catalogue Number: 261221
• Device Lot Number: J7868X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANSPACH PNEUMATIC DRILL