MAUDE Adverse Event Report: AESCULAP AG HANDLE F/PL506R & PL508R; LIGATION / VESSEL CLIPS

Model Number PL510R

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: 29 clean clip cartridges in three cartons are available for investigation.Investigation: the provided cartridges are new and unopened.No deviations can be found.The appliers are used and have been provided decontaminated.Vigilance investigator carried out the pictorial documentation visually and microscopically.Three cartridges were used for a functional test with different shaft and handle combinations.These tests were carried out successfully.After receiving the appliers in question, a functional test was carried out with each provided systems using warehouse clips out of batch 52575463.Furthermore, the jaw dimensions have been checked by aesculap technical service.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers 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 probably related to an insufficient usage and/or a lack of maintenance.Rationale: during the initial investigation of the clip cartridges, no deviations could be recognized during the functional test with our test equipment.After receiving the challenger appliers in question, functional tests could be carried out successfully.Nevertheless, with exception from one shaft (500479640), the provided shafts are no longer according the specifications due to measurement or alignment deviations.Therefore, a secure application can no longer be guaranteed.The recommended yearly maintenance interval of several components has been exceeded, therefore we recommend that the parts be serviced by aesculap technical service.Corrective action: a capa is not necessary.

Event Description

It was reported that there was an issue with the handle f/pl506r & pl508r.The event occurred in surgery during a robot-assisted nephro-ureterostomy.It was reported that the clips were ejected into the patient or remained blocked in a closed position.The clips were retrieved with no harm to the patient.The malfunction prolonged the surgery time about 5 minutes.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2019-00744 ((b)(4) pl572t), 9610612-2019-00826 ((b)(4) pl572t), 9610612-2019-00859 ((b)(4) pl572t), 9610612-2019-00951 ((b)(4) pl522r), 9610612-2019-00973 ((b)(4) pl522r), 9610612-2019-00974 ((b)(4) pl522r), 9610612-2019-00975 ((b)(4) pl522r), 9610612-2019-00976 ((b)(4) pl522r), 9610612-2019-00977 ((b)(4) pl522r).

• Brand Name: HANDLE F/PL506R & PL508R
• Type of Device: LIGATION / VESSEL CLIPS
• 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: 9723345
• MDR Text Key: 180828549
• Report Number: 9610612-2019-00952
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962493
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL510R
• Device Catalogue Number: PL510R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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