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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOBBS MEDICAL, INC. HOBBS MEDICAL POLYPECTOMY SNARE; POLYPECTOMY SNARE, SINGLE-USE

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HOBBS MEDICAL, INC. HOBBS MEDICAL POLYPECTOMY SNARE; POLYPECTOMY SNARE, SINGLE-USE Back to Search Results
Model Number 7202
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  malfunction  
Event Description
It was reported that, during a laparoscopic assisted g tube procedure, the first snare would not open or close.The second snare would not close all the way to grab the g tube and fellow had to manually put the snare out.No apparent harm to patient, although malfunction was inconvenient, and procedure was performed as booked as staff was able to pull snare out manually.Reporter indicated the issue is recurring.
 
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Brand Name
HOBBS MEDICAL POLYPECTOMY SNARE
Type of Device
POLYPECTOMY SNARE, SINGLE-USE
Manufacturer (Section D)
HOBBS MEDICAL, INC.
8 spring street
stafford springs CT 06076
Manufacturer (Section G)
HOBBS MEDICAL, INC.
8 spring street
stafford springs CT 06076
Manufacturer Contact
jennifer hodge
8 spring street
stafford springs, CT 06076
8606845875
MDR Report Key14370907
MDR Text Key299961439
Report Number1220592-2022-00002
Device Sequence Number1
Product Code OCZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K844074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/12/2022
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 Expiration Date05/01/2024
Device Model Number7202
Device Catalogue Number7202
Device Lot NumberH04-19-056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/12/2022
Initial Date FDA Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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