MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:5MM L:310MM; APPLIERS LAPAROSCOPIC

Model Number PL522R

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a challenger clip applier.Following information was reported: during surgery clips fall out of the applier into the abdomen.Several batches tried.There was no patient harm.Additional information has been requested but not yet received as of this report.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00062 ((b)(4) + pl510r).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00062 (400465062 pl510r).General information: the instruments are not available for investigation.During a surgery the clips fall out of the applier into the abdomen.Consequences for the patient: according to the available information, there were no negative consequences for patient.Investigation: no product at hand.Batch history review: pl510r / pl522r: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Pl572t: the device history records have been checked for the available lot number(s) and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing error or a material failure.There are no similar complaints against the same lot number.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably maintenance or usage related.Rationale: unfortunately due to a lack of data and without the product we can not determine the exact cause.According to the quality standard a material defect and production error can be excluded.Regarding the statement of the sales representative mic: "the mouthpiece was bent open so that the clips could not hold.", there is the possibility that the instruments does not meet the specifications.For this reason, this deviation may occur.There are several reasons for such a deviation.It is possible that a deviation has occurred during reprocessing due to improper handling.It is also possible that this could be caused by a mechanical overload situation or a leverage effect during use.Damage caused by dropping the instrument could also be a cause.If the instrument recommends maintaining could not be determined.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

• Brand Name: SHAFT COMPL.D:5MM L:310MM
• Type of Device: APPLIERS LAPAROSCOPIC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9819756
• MDR Text Key: 183089547
• Report Number: 9610612-2020-00063
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL522R
• Device Catalogue Number: PL522R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1