MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LAP.APPLIER SM 5/310MM; LAPAROSCOPIC SURGERY

Model Number PL802R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 intraoperative issue with the ds single-fire applier.During a endoscopic procedure, the clip applier was being used and a piece broke off.The piece fell behind the patient's lung and the surgeon was unable to retrieve it despite several attempts.Further details about a surgical delay or interventions such as x-rays were not specified.Patient outcome was not provided.Additional information was requested but not yet received.

Manufacturer Narrative

Investigation: no product at hand, therefore an investigation is not possible.Batch history review: we did not receive any information regarding the batch of the complained product, therefore a review of the device history records remain incomplete.Conclusion and root cause: the failure is most probably usage related.Rationale: on the basis of the provided information and the statistical analysis, we exclude a product related failure.Due to the fact that we did not receive the product, a clear conclusion can not be drawn.Within the last three years, we received six similar complaints.Five of these six complaints were reported by the same hospital, therefore we assume a usage related failure.Internally, the failure pattern could be simulated with a sample instrument.If too much force is applied several times to the instrument during the clip application, a damaging of the weldseam of the above mentioned pin is possible.The surgeon has to press the ds clip application forceps together to the stop, as mentioned in our ifu.There is no excessive force indicated during use.No capa is necessary.

• Brand Name: DS-SINGLE FIRE LAP.APPLIER SM 5/310MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8250730
• MDR Text Key: 133182774
• Report Number: 9610612-2019-00030
• Device Sequence Number: 1
• Product Code: GDO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL802R
• Device Catalogue Number: PL802R
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/17/2019
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERILE CLIPS
• Patient Outcome(s): Other
• Patient Age: 14 YR