KENDALL
Received Sep 12, 2017 · Event occurred Apr 3, 2017
Report 9612030-2017-05162 · MDR key 6858162
Device
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: (B)(6) 2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. 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
THE CUSTOMER REPORTS THAT PART OF IT KEEPS COMING OFF FROM THE BODY. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER STATED THAT THE SPONGE HEAD OF THE STICK DID COMPLETELY COME OFF INSIDE OF THE VAGINA. THE CASE WAS A OBGYN CASE. IT WAS A DILATION AND CURETTAGE. THE SPONGE HEAD WAS RETRIEVED WITH A PAIR OF SPONGE FORCEPS.
Additional Manufacturer Narrative
THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE REPORTED CONDITION BY THE CUSTOMER COULD NOT BE CONFIRMED WITHOUT A PHYSICAL SAMPLE OR PICTURE SUBMITTED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. DUE TO THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION; CONDITIONS REPORTED COULD NOT BE CONFIRMED TO DETERMINE A ROOT CAUSE. SINCE NO DEFECTIVE CONDITION AND ROOT CAUSE WAS IDENTIFIED, NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY AT THIS MOMENT. THE CURRENT PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA. A PRODUCTION NOTIFICATION WAS PERFORMED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.