SCALPEL HANDLE #3 125MM
Received Jul 16, 2026 · Event occurred Jul 7, 2026
Report 9610612-2026-00149 · MDR key 25840200
Device
Generic name
General Surgical Instruments
Manufacturer
Aesculap AgModel number
BB073RCatalog number
BB073R
Product problems
- Component or Accessory Incompatibility
Patient
NA · Unknown
- Laceration(s)
Narrative
Description of Event or Problem
AN ADVERSE EVENT WAS REPORTED INVOLVING THE MEDICAL DEVICE BB073R - SCALPEL HANDLE #3 125MM. SPECIFICALLY, IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY WHILE ATTACHING THE SCALPEL BLADE TO THE HANDLE. THE BLADE SUBSEQUENTLY SLIPPED, RESULTING IN AN INJURY TO THE USER. THE USER IS CURRENTLY AWAITING HAND SURGERY FOR NERVE REPAIR. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.