MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS DEL CVD 230MM; DUROTIP SCISSORS

Model Number BC277R

Device Problems Mechanical Problem (1384); Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received a complaint about seven pairs of scissors.According to the customer, the pairs of scissors are no longer cutting according to the desired quality.Furthermore, there are ten pairs of scissors in the hospital labelled with bc275r but they are 230mm long instead of 200mm.According to the available information, there were no negative consequences for the patient.All provided pairs of scissors are in used condition.Vigilance investigator carried out the pictorial documentation visually and microscopically.The dimensions of all provided products were checked.The labelling of the two products of complaint is not correct.The scissors are 230mm long instead of 200mm.Tus, they should have been labelled with the ref bc277r.All other provided scissors are labelled correctly.According to the q-coordinator of the production plant, quality assurance analyzed the case of mislabeling scissors bc275r.Orders bc275r and bc277r have been produced and released to laser marking department the same day.Most, likely the exchange of documentation did not take place during laser labeling and is traceable to an individual human mistake since the design of the scissors are very similar.A follow up training of all involved person will be initiated.Furthermore a cutting test was carried out.The insufficient cutting performance of the concerned products is most likely caused by wear and tear, due to the age and number of applications during this time.The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.One similar incidents (wrong labelling) have been filed with products from batch 4507560233.No similar incidents (insufficient cutting) have been filed with products from these batches.Based on the information available as well as a result of our investigation the root cause of the wrong labelling is most probably related to a manufacturing error.

Event Description

It was reported by the healthcare professional "the wrong item numbers are on the scissors".All med watch submissions related to this are: 9610612-2019-00222 (this report), 9610612-2019-00223.

• Brand Name: TC METZENBAUM SCISSORS DEL CVD 230MM
• Type of Device: DUROTIP SCISSORS
• 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
• MDR Report Key: 8478262
• MDR Text Key: 144974187
• Report Number: 9610612-2019-00222
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2019

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 Model Number: BC277R
• Device Catalogue Number: BC277R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1