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 2020-01-08 for JAW INS.BIP.MARYLAND DISS.FEN.5/310MM PM438R manufactured by Aesculap Ag.
[179479932]
Manufacturing site evaluation: failure description: the instrument arrived with status "hygienically safe" with visible damage but without a broken off fragment. Investigation: the investigation was performed with following analysis equipment: digital microscope "keyence vhx-5000" (eq. -nr. : (b)(4)), digital camera dmc-tz61, object holder, graph paper. We made a visual inspection of the instrument. Here we found a bent rod , missing blue ceramic part, a broken grey ceramic and misaligned jawparts. Batch history review: the device quality and manufacturing history records have been checked for the lot number (62033443) and found to be according to the specification, valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: the root cause of the problem is most probably usage related. Rationale: according to the quality standard a production error and a material defect can be excluded. Investigations lead to the assumption that the ceramic breakages and the misaligned jaw parts caused by an improper handling due to a mechanical overload situation. Possibly an excessive force has been applied on the instrument or the possibility of torsion or high leverage with the instrument. The bent rod is further indication for improper handling with high usage forces. According to the instructions for use (ifu) there is a caution: "damage to the working insert due to incorrect handling or operation! To avoid damage to the working tip, especially to the ceramic insulation: apply caution when operating the product - do not apply excessive force - protect the working tip against knocks and impacts - use the pin protector when the product is not in use". No capa necessary.
Patient Sequence No: 1, Text Type: N, H10
[179479933]
It was reported that there was an issue with the maryland dissector. The patient was undergoing a gynecological hysterectomy. While the joint of the instrument was moving, a blue piece of insulation detached and fell into the patient. It was removed immediately. A replacement with the same type of instrument was used and the procedure was finished successfully. There was a surgical delay of 5-10 minutes. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00897 |
| MDR Report Key | 9565949 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2019-11-29 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2020-01-08 |
| 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 | JAW INS.BIP.MARYLAND DISS.FEN.5/310MM |
| Generic Name | LAPAROSCOPIC SURGERY |
| Product Code | HGI |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-10 |
| Model Number | PM438R |
| Catalog Number | PM438R |
| Lot Number | 62033443 |
| 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 | 2020-01-08 |