MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #15 BASIC INSTRUMENTS

Model Number BB515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the scalpel blade. While attempting to insert a blade onto the handle, the assistant cut herself deeply in her thumb. The blade was noted to have "jumped" out of the packaging. It was reported that the assistant was doing well and in the healing process. Further information has been requested.

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8511625
• Report Number: 9610612-2019-00269
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: 4509129959
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 04/10/2019
• Device Age: 14 MO
• Event Location: No Information
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Other