MAUDE Adverse Event Report: AESCULAP AG SENSATION MICROSCIS S/S BAY STR 70/195MM; INSTRUMENTS FOR NEUROSURGERY

Model Number FM121R

Device Problem Failure to Cut (2587)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: we received a pair of scissors for investigation decontaminated.The instrument is in mint condition, but the screw is not tightened.Visual investigation: the connection screw is not tightened according to the specifications, thus a functional test could not be carried out successfully.Since the specification is an inspect dimension, it can be excluded that the scissors were delivered in that condition.An insufficient oiling after reprocessing could trigger a loosening of the connection screw.Due to high friction caused by the missing lubrication, the self-locking is no longer sufficient to prevent the screw from loosening.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.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 an insufficient maintenance of the device.Rationale: based on the investigation and the device history records (dhr) we exclude a manufacturing or material related error.According to the (ifu), the moving parts must be lubricated prior to function test: "damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication - prior to function checks, lubricate moving parts (e.G.Joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.G.For steam sterilization: aesculap sterilit i oil spray jg600 or drip lubricator jg598)".

Event Description

It was reported that there was an issue with the micro scissors.During cerebro-neuro procedure, the micro-scissors did not cut.It was noted during the first use of the 2 scissors, and there was some tearing of tissue.The first scissor also had a screw loosen.No intervention was required and there was no surgical delay reported.The patient was not harmed and there were no injuries or consequences.Additional information was not provided.Associated medwatches: (2 scissors reported separately).

• Brand Name: SENSATION MICROSCIS S/S BAY STR 70/195MM
• Type of Device: INSTRUMENTS FOR NEUROSURGERY
• 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: 8741312
• MDR Text Key: 149554758
• Report Number: 9610612-2019-00428
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: FM121R
• Device Catalogue Number: FM121R
• Device Lot Number: 52489626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1