UNIVERSAL SCISSORS RED 180MM
Received Nov 6, 2017 · Event occurred Oct 13, 2017
Report 9610612-2017-00539 · MDR key 7003773
Device
Generic name
Universal, Bandage, Plaster Scissor
Manufacturer
Aesculap AgModel number
BC980RCatalog number
BC980R
Lot number
4507471190
Product problems
- Defective Device
- Defective Device
Patient
Not reported
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6).
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE RESPONSIBLE SUPPLIER QUALITY MANAGER. AFTER REVIEWING THE TEST PLAN, THE SCISSORS FOUND TO BE ACCORDING RO THE SPECIFICATION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: BASED ON THE QUALITY STANDARDS AND THE DHR-REVIEW, WE EXCLUDE A MATERIAL OR MANUFACTURING CAUSED ERROR. IN GENERAL, TOO MUCH PRESSURE ON THE SKIN DURING CUTTING CAN CAUSE ABRASION. NO CAPA IS NECESSARY.