SPOON FORCEPS LONG,SERRAT
Received Jun 2, 2023 · Event occurred Mar 15, 2023
Report 1216677-2023-00091 · MDR key 17050528
Device
Generic name
Spoon Forceps Long,serrat
Manufacturer
Coopersurgical, Inc.Model number
ES-LNGRCatalog number
ES-LNGR
Lot number
639164
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G2: COLOMBIA DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM REDA INSTRUMENTE - GMBH ON 06-05-20. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. IF THE INCOMING INSPECTION RECORD SHOULD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS OF BEING DAMAGED. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. CUSTOMER HAS PROVIDED A PHOTO OF THE SPOON FORCEPS; HOWEVER, IT DOES NOT CONFIRM THE COMPLAINT. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPER SURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.
Description of Event or Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
THE REPORTED CONDITION IS BEING INVESTIGATED.
Description of Event or Problem
IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE DEVICE WAS DAMAGED. PER THE REPORTER, "THE INTERNAL PART OF THE CLAMP WAS SKINNED." NO ADVERSE EVENT WAS REPORTED.