Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM STAPLER; STAPLE, IMPLANTABLE
  • 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
 

ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM STAPLER; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number TL90
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/20/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
 
Event or Problem Description
It was reported that during an open colectomy procedure that while trying to staple they closed the handle and no staples were deployed.Another device was used to complete the procedure.Surgeon stated that she may have closed the handle prior to positioning the device and may have fired the device prior to the intended use.There were no adverse consequences for the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key8424852
Report Number3005075853-2019-17304
Device Sequence Number1147648
Product Code GDW
UDI-Device Identifier10705036013198
UDI-Public10705036013198
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K020779
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/20/2019
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
Operator of Device Health Professional
Device Expiration Date10/31/2019
Device Catalogue NumberTL90
Device Lot NumberL92Z01
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/20/2019
Initial Report FDA Received Date03/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-