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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR FIXEDPIN HEMOSTATIC PROBE

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GYRUS ACMI, INC 7FR FIXEDPIN HEMOSTATIC PROBE Back to Search Results
Model Number CD-B622LA
Device Problems Defective Device (2588); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation. Therefore, the root cause of the reported phenomenon could not be determined at this time. This report will be supplemented accordingly following investigations.
 
Event Description
It was reported that the device probe did not worked. The probe stopped functioning. The issue occurred during an upper endoscopy procedure. The defective probe was replaced with another probe. The intended procedure was completed successfully with no harm or injury to the patient. No user injury was reported.
 
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Brand Name7FR FIXEDPIN HEMOSTATIC PROBE
Type of Device7FR FIXEDPIN HEMOSTATIC PROBE
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key12063893
MDR Text Key280518097
Report Number3011050570-2021-00079
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K123319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCD-B622LA
Device Lot NumberKR110577
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No

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