MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #23; GENERAL SURGICAL INSTRUMENTS

Model Number BB523

Device Problem Break (1069)

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

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that a broken scalpel blade had to be removed from the abdomen.No surgery delay reported.No harm to the patient reported.Components in use listed as concomitant devices are: bb523 / carbon steel scalpel blades #2.Bb085r / scalpel #4l.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We opened a closed dispenser packaging and made a visible inspection of an unused surgical blade bb523.Here we found no visible failure.Furthermore we made a visual inspection of the scalpel #4l bb085r.Here we found traces of usage but no failure.Hardness of the instrument was checked and according to specification, it is not in the allowable tolerance.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: the higher than normal hardness only has increased strength as a consequence.Furthermore the ductility decreased but we do not regard this as the decisive reason.We assume that a mechanical overload or high leverage with the instrument as a causal factor.No similar incidents have been filed with products from this batch.No capa is necessary.

• Brand Name: CARBON STEEL SCALPEL BLADES #23
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6225292
• MDR Text Key: 64343440
• Report Number: 9610612-2017-00006
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: BB523
• Device Catalogue Number: BB523
• Device Lot Number: 4507771097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/16/2016
• Device Age: 5 MO
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: 12/14/2016
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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
• Treatment: BB085R / SCALPEL #4L; BB523 /CARBON STEEL SCALPEL BLADES #2
• Patient Outcome(s): Other