• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP BALL ELECTRODES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOPERSURGICAL, INC. LEEP BALL ELECTRODES Back to Search Results
Model Number B0512
Device Problem Component Missing (2306)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical is currently investigating the reported complaint condition. Once the investigation is complete a follow up report will be filed. Reference e-complaint-(b)(4). 10/3/2017 update: investigation: analysis and findings: the root cause of the reported event that the "dr could not get the b0512 ball electrode in the olsen 950 hand piece" cannot be verified, and is considered indeterminable as the affected device was not returned for evaluation, and the condition, or state of the olson 950 hand piece could not be determined. However, if the affected device is returned in the future and made available, the complaint may be reopened and addressed as needed. The process of manufacturing the ball electrode ensures that each electrode is free of any damage and is conforming as per in-process work instructions. Although indeterminable, it's possible that the electrode may have been damaged after it was shipped from the csi fg (b)(4) warehouse. A review of the lot dhr indicated it was manufactured two years prior to the reported event. The dhr did not reveal any abnormality. Corrective actions: corrective action is not warranted at this time as the affected device was not returned per scrap rma # (b)(4). A review of the manufacturing process did not reveal any changes and showed it to be stable. No further action is required at this time. Reason: per (b)(4), this complaint will be monitored for trending in that no injury was reported to end user or patient. Was the complaint confirmed? no.
 
Event Description
"dr (b)(6) could not get the b0512 in the olsen 950 hand piece. Lot number is 173808. All disposed of at site. The patient bled heavily until he could stop with lugols. The patient is ok. " reference e-complaint-(b)(4).
 
Manufacturer Narrative
Coopersurgical is currently investigating the reported complaint condition. Once the investigation is complete a follow up report will be filed. (b)(4).
 
Event Description
"dr (b)(6) could not get the b0512 in the olsen 950 hand piece. Lot number is 173808. All disposed of at site. The patient bled heavily until he could stop with lugols. The patient is ok. " (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEEP BALL ELECTRODES
Type of DeviceLEEP BALL ELECTRODES
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate dr
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate dr
trumbull CT 06611
Manufacturer Contact
nana banafo
75 corporate dr
trumbull, CT 06611
2036015200
MDR Report Key6805731
MDR Text Key253215941
Report Number1216677-2017-00057
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K905747
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Model NumberB0512
Device Catalogue NumberB0512
Device Lot Number173808
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/18/2017 Patient Sequence Number: 1
-
-