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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. BIB REMOVAL TOOL WIRE GRASPER
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APOLLO ENDOSURGERY, INC. BIB REMOVAL TOOL WIRE GRASPER Back to Search Results
Model Number B-40814
Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
Event Type  Injury  
Manufacturer Narrative
Initial medwatch submitted to the fda on (b)(6) 2021.The device was returned to the apollo device analysis laboratory on 03/may/2021.Analysis of the device is ongoing.
 
Event Description
Physician experienced difficulties in removing the balloon as the grasper malfunctioned.
 
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Brand Name
BIB REMOVAL TOOL WIRE GRASPER
Type of Device
WIRE GRASPER
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s. capital of texas hwy
bldg 1, ste. 300
austin TX
Manufacturer (Section G)
PRIMO MEDICAL GROUP
75 mill street
stoughton MA 02072
Manufacturer Contact
david hooper
1120 s. captail of texas hwy
bldg 1, ste 300
austin, TX 78746
MDR Report Key11793233
MDR Text Key256242823
Report Number3006722112-2021-00031
Device Sequence Number1
Product Code OCZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberB-40814
Device Catalogue NumberB-40814
Device Lot Number2833109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received05/07/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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