MAUDE Adverse Event Report: AESCULAP AG ENDOSCOPIC MYOMA FIXATION INSTRUMENT; GYNAECOLOGY: RESECTOSCOPE / HYSTER

Model Number PL430R

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

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

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported "that the tip broke off during a laparoscopic hysterectomy procedure.The myoma screw was placed into the uterine wall and broke during surgery.The tip was retrieved and removed from the patient." no x-rays were needed to retrieve the tip.Additional patient outcome information has been requested and when the information become available it will be forwarded over.

Manufacturer Narrative

No products at hand.There a failure description is not possible.No product at hand.There an investigation is not possible.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.Based on the information available it is not possible to determine a possible root causes for the failure.It could be possible that the failure is usage related.Due to the circumstances that we did not receive the device for the investigation is it not possible to determine a conclusion and root cause.In light of past experience and without any further information we assume that the complained instrument was overload either during the application itself or during reprocessing or by being dropped on a hard surface.A capa is not necessary.

• Brand Name: ENDOSCOPIC MYOMA FIXATION INSTRUMENT
• Type of Device: GYNAECOLOGY: RESECTOSCOPE / HYSTER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8080273
• MDR Text Key: 127858261
• Report Number: 9610612-2018-00519
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K943603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL430R
• Device Catalogue Number: PL430R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2018
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1