inforMED
MalfunctionGET

ENDO BABCOCK

Received Aug 29, 2017 · Event occurred Aug 1, 2017

Report 1219930-2017-06786 · MDR key 6828407

Device

Generic name

Motor, Surgical Instrument, Pneumatic Powered

Model number

174001

Catalog number

174001

Lot number

P6L0126X

Product problems

  • Break
  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. NOTHING FELL INTO THE PATIENT CAVITY. ANOTHER SIMILAR DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE DISTAL END OF THE SHAFT WAS BROKEN PROXIMAL TO THE JAWS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY BE DUE TO ROUGH HANDLING OF THE DEVICE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.