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

Model Number BB515

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

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Nerve injury (spinal opening) during median nerve release interventions during several interventions called carpal tunnel with patient outcomes complaining of scar burn and in the median nerve area.Scar burns (about 10 for 50 procedures) in the median nerve area with algodystrophy (3 out of 10) and prolongation of sick leave for some patients.

Manufacturer Narrative

Investigation: no product is available for investigation.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available and the quality standards we exclude a material or manufacturer related error.Rational: we can not detect a causal relation between the products and the mentioned patient hazard.No capa is necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #15
• Type of Device: SCALPEL BLADES
• 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: 6918007
• MDR Text Key: 89391022
• Report Number: 9610612-2017-00501
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: RE
• 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
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB515
• Device Catalogue Number: BB515
• Device Lot Number: L8202262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/04/2017
• Date Manufacturer Received: 09/15/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other