RAPTOR GRASPING DEVICE
Received Jan 6, 2022 · Event occurred Dec 21, 2021
Report 1528319-2022-00001 · MDR key 13175201
Device
Generic name
Grasping Device
Manufacturer
United States Endoscopy Group, Inc.Catalog number
00711177
Lot number
2110116
Product problems
- Difficult to Open or Close
- Adverse Event Without Identified Device or Use Problem
- Difficult to Open or Close
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE THE JAW COMPONENTS ON THE RAPTOR GRASPING DEVICE COULD NOT BE CLOSED. THE ENDOSCOPE WAS WITHDRAWN WITH THE DEVICE JAWS IN THE OPEN POSITION. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER OF THE DEVICE.
Additional Manufacturer Narrative
THE DEVICE SUBJECT OF THE EVENT WILL BE RETURNED TO US ENDOSCOPY FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE DEVICE LOT WAS MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. STATEMENTS IN THE INSTRUCTIONS FOR USE INCLUDE: "ACTUATE THE DEVICE BY MOVING THE SLIDER ON THE HANDLE BACK AND FORTH TO CONFIRM THAT THE GRASPING JAWS OPEN AND CLOSE SMOOTHLY. IF THE UNIT DOES NOT FUNCTION PROPERLY, OR THERE IS EVIDENCE OF DAMAGE (E. G. BENDS, KINKS, MISSHAPEN JAWS, MISALIGNED JAWS, EXPOSED WIRES) DO NOT USE THIS PRODUCT AND CONTACT YOUR LOCAL PRODUCT SPECIALIST. DO NOT USE EXCESSIVE FORCE ON THE HANDLE AND DO NOT COIL THE CATHETER OUTSIDE OF THE ENDOSCOPE. EXCESSIVE FORCE OR COILING MAY DAMAGE THE DEVICE OR DAMAGE THE ENDOSCOPE AND MAY RESULT IN ACCIDENTAL INJURY TO THE PATIENT OR CLINICIAN. THE FOLLOWING CONDITIONS MAY CAUSE THE DEVICE TO FUNCTION IMPROPERLY: ADVANCING THE HANDLE TO THE OPEN POSITION WITH TOO MUCH SPEED OR FORCE. ATTEMPTING TO PASS OR OPEN THE DEVICE IN AN EXTREMELY ARTICULATED ENDOSCOPE. ATTEMPTING TO ACTUATE THE DEVICE IN AN EXTREMELY COILED POSITION. ACTUATING THE DEVICE WHEN THE HANDLE IS AT AN ACUTE ANGLE IN RELATION TO THE SHEATH. " US ENDOSCOPY WILL OFFER IN-SERVICE TRAINING ON THE USE OF THE RAPTOR GRASPING DEVICE TO THE USER FACILITY. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
THE STERIS ENDOSCOPY ENGINEERING TEAM EVALUATED THE COMPONENTS SUBJECT OF THE REPORTED EVENT. THE TEAM FOUND EVIDENCE OF THE DEVICE BEING ACTUATED IN AN EXTREMELY COILED POSITION. THE INSTRUCTIONS FOR USE STATES, "EXCESSIVE FORCE OR COILING MAY DAMAGE THE DEVICE OR DAMAGE THE ENDOSCOPE AND MAY RESULT IN ACCIDENTAL INJURY TO THE PATIENT OR CLINICIAN." BASED ON THIS EVALUATION, THE ROOT CAUSE CAN BE ATTRIBUTED TO CUSTOMER HANDLING. THE DISTRIBUTOR OFFERED IN-SERVICE, BUT THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.