TC TENOTOMY SCISSDELCVD1/SERR130MM
Received Mar 15, 2018 · Event occurred Aug 29, 2016
Report 9610612-2018-00100 · MDR key 7343488
Device
Generic name
Dental Scissors
Manufacturer
Aesculap AgModel number
DO250RCatalog number
DO250R
Lot number
4507434213
Product problems
- Break
- Material Integrity Problem
- Break
- Material Integrity Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: THE TIP OF THE SCISSORS ARE BROKEN. PICTORIAL DOCUMENTATION WAS CARRIED OUT WITH A DIGITAL MICROSCOPE. HARDNESS MEASUREMENT WAS CARRIED OUT WITH HARDNESS TESTER. THE DEVICE HISTORY FILES HAVE BEEN CHECKED AND WERE FOUND TO BE ACCORDING TO THE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. THIS KIND OF INSTRUMENT IS DESIGNATED FOR DELICATE USE ONLY. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. THE VISUAL INVESTIGATION AND THE HARDNESS TEST INDICATED THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE. A CAPA IS NOT NECESSARY.
Description of Event or Problem
COUNTRY OF COMPLAINT: USA. CUSTOMER STATES THAT DURING INTRA-OPERATIVE SURGERY THE TIP OF SCISSORS BROKE OFF. NO SURGICAL DELAY AND NO PATIENT INJURY REPORTED.