MAUDE Adverse Event Report: AESCULAP AG TC TENOTOMY SCISSDELCVD1/SERR130MM; DENTAL SCISSORS

Model Number DO250R

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the tip of the scissors are broken.Pictorial documentation was carried out with a digital microscope.Hardness measurement was carried out with hardness tester.The device history files have been checked and were found to be according to the specifications.Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage.This kind of instrument is designated for delicate use only.It is liable that a mechanical overload situation led to the breakage.The visual investigation and the hardness test indicated that the quality requirements are in the specified tolerance range.A capa is not necessary.

Event Description

Country of complaint: usa.Customer states that during intra-operative surgery the tip of scissors broke off.No surgical delay and no patient injury reported.

• Brand Name: TC TENOTOMY SCISSDELCVD1/SERR130MM
• Type of Device: DENTAL 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: 7343488
• MDR Text Key: 102582680
• Report Number: 9610612-2018-00100
• Device Sequence Number: 1
• Product Code: EGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2018

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 Model Number: DO250R
• Device Catalogue Number: DO250R
• Device Lot Number: 4507434213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Distributor Facility Aware Date: 02/27/2018
• Device Age: 23 MO
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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
• Patient Outcome(s): Other