MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-18 for HANDLE F/PL506R & PL508R PL510R manufactured by Aesculap Ag.
[180828549]
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.
Patient Sequence No: 1, Text Type: N, H10
[180828550]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00952 |
| MDR Report Key | 9723345 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDLE F/PL506R & PL508R |
| Generic Name | LIGATION / VESSEL CLIPS |
| Product Code | OCW |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-01-20 |
| Model Number | PL510R |
| Catalog Number | PL510R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |