MalfunctionGDF
ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER
Received May 25, 2011 · Event occurred May 2, 2011
Report 2210968-2011-00682 · MDR key 2103115
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2011 AND AN ENDOSCOPIC NEEDLE HOLDER WAS USED. DURING THE PROCEDURE, THE NEEDLE HOLDER WOULD NOT RELEASE WHEN CLAMPED DOWN ON SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Remedial action
- Other