MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIOPSY FCPS W/TEETH 5MM 310MM; REUSABLE INSTRUMENTS

Model Number PO652R

Device Problems Material Separation (1562); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

When new information becomes available a follow up report will be submitted.

Event Description

It was reported that during a laparoscopic hysterectomy procedure one of the two tooth's detached from the biopsy forceps and fell into the patient.It was retrieved.This incident did not cause or contribute to serious injury or death or a delay in surgery.No other information has been provided.

Manufacturer Narrative

Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: e2014018 no product at hand, therefore an investigation was not possible.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.We assume that the cause of the failure is not product related.There is the possiblity that the root cause of the problem is most probably 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.There is the possibility for a usage error due to improper handling or mechanical overload situation by torsion or high leverage with the instrument.If further investigations are required, the product should be provided for examination.No capa necessary.

• Brand Name: JAW INS.BIOPSY FCPS W/TEETH 5MM 310MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8458204
• MDR Text Key: 140145870
• Report Number: 9610612-2019-00221
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K010752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO652R
• Device Catalogue Number: PO652R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/18/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1