MAUDE Adverse Event Report: AESCULAP AG SURGICAL SCISSORS STR S/S 130MM; BASIC INSTRUMENTS

Model Number BC343R

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the scissors were not available for investigation, but pictures provided by the customer.According to the available information, there were no negative consequences for the patient.These scissors were manufactured according to the "quality standard scissors" valid at the time of production.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.For further investigations, the product is required for examination.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.

Event Description

It was reported that there was an issue with a surgical scissors str s/s 130mm.According to the complaint description the scissors is not cutting at the tip and 2/3 length of blade.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00280 (400474102 + bc343r).

Event Description

Associated medwatch-reports: 9610612-2020-00281 ((b)(4)+ bc343r), and 9610612-2020-00280 ((b)(4)).

Manufacturer Narrative

Investigation results: the complaint devices were provided for investigation.Investigation was carried out visually and cutting performance tests have been carried out with all provided pairs of scissors.The failure mentioned by the customer could be confirmed.There are no similar complaints against the same lot number with this error pattern.The root cause is most probably manufacturing related.Due to the circumstances that a systematic error can be excluded a capa is not necessary.For preventive actions the quality coordinator of the production plant was informed to initiate preventive actions.

• Brand Name: SURGICAL SCISSORS STR S/S 130MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10270927
• MDR Text Key: 201610539
• Report Number: 9610612-2020-00281
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC343R
• Device Catalogue Number: BC343R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1