MAUDE Adverse Event Report: AESCULAP AG CUTTING PLIER F/WIRE 470MM; BASIC INSTRUMENTS

Model Number LX164R

Device Problems Component Missing (2306); Defective Device (2588)

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

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing evaluation: investigation: the instrument was available for investigation decontaminated.The instrument is in a used condition.Both blades are crushed, deformed, and no longer even.The blades are crushed but not fractured.The original labelling was taped and the surface was sandblasted.Based on the taped surface and foreign labelling, we assume that a third party carried out maintenance.The uneven blades are caused by tumbling components, caused by the loosened nuts.In addition, one of the nuts is missing.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 likely related to third party maintenance or improper reprocessing.Rationale: there is the possibility that during this maintenance the nuts have not been tightened according to the aesculap specifications valid at the time of production; therefore, a tumbling of the components and a release of the nuts cannot be excluded.Another possibility is that the instrument has been dismantled for reprocessing, and have not been tightened accordingly.The tumbling of the components is most likely also the reason for the damaged blades, since a proper cutting performance is no longer possible.Furthermore, after each reprocessing the instrument needs to undergo an inspection for loosened or damaged components.No capa required.

Event Description

It was reported that there was an intraoperative issue with the wire cutting pliers.During an unspecified procedure, the product fell apart and several nuts fell into the patient.All pieces were retrieved and there was no surgical delay.It was confirmed that after opening the packet, the 5th bolt was noted as already missing; 4 bolts were accounted for following the procedure.

• Brand Name: CUTTING PLIER F/WIRE 470MM
• Type of Device: BASIC INSTRUMENTS
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8828206
• MDR Text Key: 153579456
• Report Number: 9610612-2019-00474
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LX164R
• Device Catalogue Number: LX164R
• Device Lot Number: 4505393118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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