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U.S. Department of Health and Human Services

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

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RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
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.
 
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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 Key10326867
MDR Text Key202032608
Report Number3014334038-2020-00002
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
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 Number261221
Device Lot NumberJ7868X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2020
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received07/27/2020
Supplement Dates Manufacturer Received08/11/2020
Supplement Dates FDA Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANSPACH PNEUMATIC DRILL
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