MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #12D GENERAL SURGICAL INSTRUMENTS

Model Number BB542

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

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 bb542 - carbon steel scalpel blades #12d. According to the complaint description, it was reported that the blades broke inside patient's mouth and remained in the gum. Additional information received, that three scalpel blades of the mentioned type of it happened that the tip of the blade broke off during a standard operation ("unfolding"). The broken off parts were about 0. 5mm to 1mm long. There were no patient injuries, i. E. Up to now such injuries are not known. However, it can not rule out the possibility that further splinters of the blades may be discovered in future x-rays. The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically. The scalpel blade's form is relatively thin in comparison with the shape of the drawing. Therefore a breakage of the tip is possible. In a further complaint during a test with unopened samples the deformation and breakage of the tip could be reproduced by tipping the tip with force to a hard surface. Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production. Review of the complaint history revealed that one similar complaint has been filed against products from this batch number. The review of the risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is acceptable. Conclusion and measures/preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure. Specifically, the form of the scalpel blade's tip is not according to the specification. This is caused by a manufacturing issue and has not been detected during final inspection, due to a slip through. This issue has been investigated by the manufacturing plant and corrective actions has been planned and will implemented. A product safety case will be requested. Any action regarding capa will be addressed with this case.

• Brand Name: CARBON STEEL SCALPEL BLADES #12D
• Type of Device: GENERAL SURGICAL 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11148321
• Report Number: 9610612-2020-00967
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BB542
• Device Catalogue Number: BB542
• Device Lot Number: 4510945749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention