MAUDE Adverse Event Report: AESCULAP AG MUELLER MICRO-SCISSORS CVD S/S 170MM; GENERAL INSTR.CARDIOVASC.& THO

Model Number FM041R

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instrument is not available for investigation.The instrument was repaired locally near the user facility.Investigation: no product at hand.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most likely usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.They repaired them locally.There is the possibility for usage error due to improper handling.This could have caused a damaged blade and led to insufficient cutting ability.If investigations are required, the product should be provided for examination in the complained status.Furthermore, according to instructions for use (ifu), the following points must be observed: "prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components; do not use the product if it is damaged or defective; set aside the product if it is damaged; replace any damaged components immediately with original spare parts." "after each complete cleansing, disinfecting, and drying cycle, check that the product is dry, clean, operational, and free of damage (e.G.Broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components.); check that the product functions correctly; immediately put aside damaged or inoperative products and send them to ats, see technical services".

Event Description

It was reported that there was an issue with the micro scissor.During inspection, the scissor failed due to a malfunction.It was noted that it did not cut adequately.There was no patient harm or procedure involved.The facility staff was concerned that it posed a potential risk because it was to be used for delicate tissue surgeries.Additional information was not available.

• Brand Name: MUELLER MICRO-SCISSORS CVD S/S 170MM
• Type of Device: GENERAL INSTR.CARDIOVASC.& THO
• 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8741300
• MDR Text Key: 149783308
• Report Number: 9610612-2019-00434
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM041R
• Device Catalogue Number: FM041R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Date Manufacturer Received: 06/05/2019
• 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: Unknown
• Patient Sequence Number: 1