MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #11

Model Number BB511

Device Problems Failure to Cut (2587); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6). It was reported that several blades does not cut, use of 3-4 blades per intervention.

Manufacturer Narrative

Investigation: no product is at hand. Batch history record: the device history records have been checked and found to be according to the specification, valid at the time of production. There is no indication of a material or manufacturing defect. No other complaints are filed with materials with this batch number. Conclusion and root cause: based on the information available, the root cause of the failure is most probably related to an insufficient usage. Rational: based on the quality standards, we exclude a material or manufacturer caused error. It is possible that an insufficient usage resulted in the described failure. No capa is necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #11
• Type of Device: SCALPEL BLADES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7685215
• MDR Text Key: 113888492
• Report Number: 9610612-2018-00277
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2021
• Device Model Number: BB511
• Device Catalogue Number: BB511
• Device Lot Number: 4507752624
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 06/13/2018
• Device Age: 2 YR
• Event Location: No Information
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/13/2018 Patient Sequence Number: 1