MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS CVD 180MM; DUROTIP SCISSORS

Model Number BC263R

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

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 a metzenbaum scissors.It was reported that the scissor broke at the tip.This incident did occur in surgery.This incident did not cause or contribute to serious injury or death or a delay in surgery.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing side evaluation: we received a complaint about a broken off tip of a pair of scissors.The broken pair of scissors is available for investigation decontaminated, but not the broken off tip.According to the available information, there were no negative consequences for the patient.Investigation: the pair of scissors is in a bad condition, the tip of the lower shear blade is broken off.Vigilance investigator carried out the pictorial documentation visually1 and microscopically2.The tip of the lower shear blade is broken off, the fragment is not available.The biseaus of the blades are grinded improperly several bevels can be found.This indicates a third party maintenance.Furthermore, no ats stamp can be found on the surface of the provided pair of scissors.At the joint area of the lower shear blade a crack can be found.A cutting test according to the qstd was carried out, but failed due to the poor blade geometry.At the back of the lower shear blades pitting corrosion is recognizable.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to a third party maintenance of the device.Rationale: the root cause of the failure was most likely caused by an overload situation e.G.Leverage or torsion due to the poor blade geometry caused by the third party maintenance.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Type of Device: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9286215
• MDR Text Key: 178639375
• Report Number: 9610612-2019-00747
• Device Sequence Number: 1
• Product Code: LRW
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC263R
• Device Catalogue Number: BC263R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1