MAUDE Adverse Event Report: AESCULAP AG AXIAL RIING HANDLE ONLY RATCHET/LOCK; REUSABLE INSTRUMENTS

Model Number PM957R

Device Problem Use of Device Problem (1670)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the instruments are in a good condition, no deviations can be found with the naked eye.The vigilance investigator carried out the pictorial documentation visually.According to the investigation carried out by the q-coordinator of the production plant, the device are according to the specifications valid at the time of production.Based on the drawings, "the clamp must not close when jaws are closed" to ensure a proper function during applications.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is related to insufficient usage.Rationale: according to the responsible q-coordinator the provided instruments are according to the specifications valid at the time of production.Therefore, we assume a usage related error, e.G.Due to too much tissue between the jaws during application.No capa necessary.

Event Description

It was reported there was an issue with the intra-operative clamps.During an attempted partial nephrectomy, as the clamp was being used on the renal artery, it was noted that it was not "strong" enough and not applying enough pressure.The procedure was changed to a radical nephrectomy due in part to the malfunction.The devices were returned for investigation and it was noted that the returned devices were both two disassembled craford endo-vascular clamps with short jaws.The concomitant devices (involved components) returned were insulated outer tubes x 2 and optional handles for customizing instruments both with a ratchet lock on the handle.This report relates to the ring handle.Associated medwatches: 9610612-2019-00320, 9610612-2019-00319.

• Brand Name: AXIAL RIING HANDLE ONLY RATCHET/LOCK
• Type of Device: REUSABLE 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 ; am aesculap-platz; tuttlingen, baden-wurttemberg 78501 ; GM 78501
• MDR Report Key: 8776904
• MDR Text Key: 152110099
• Report Number: 9610612-2019-00456
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992053
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM957R
• Device Catalogue Number: PM957R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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