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

Model Number PL522R

Device Problem Mechanical Problem (1384)

Patient Problems Hemostasis (1895); Patient Problem/Medical Problem (2688)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation: the investigation was carried out visually and microscopically.The visual inspection revealed a broken welding joint between the outer tube and the handle seat.An optical inspection of the outer tube detected scratches and grooves.A visual inspection of the handle seat found no visible damage or failure.Due to the broken welding joint a functional test is not possible.The instruments were sent to the quality assurance of the production department for further investigation.Batch history review: the device quality and manufacturing history records have been checked for all the lot number (622971000/62295653) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: without the cartridge it is not possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: according to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the broken welding joint could have been caused due to an improper handling.Without the cartridge is not possible to determine an exact cause.There is the possibility for a damaged cartridge by an assembly error.This could have caused the jump out of the cartridge during use.According to the investigation report of the quality assurance of the production department: "specification- according to the guardus test plan: magazine does not disengage when the clip closes at the magazine nose.Current state: the hand was tested for correct function with the test shaft and the function gauge.The correction function is given.No disengagement of the magazine at the clip closure at the magazine nose.The weld seam at the distal shaft end is broken.There is no error on production side.The function of the handle is ok.Due to overstrain by the user, the weld broke at the distal end.Since we do not have the magazine used during the operation, the cause of the magazine jumping out during the operation cannot be clearly determined.No capa necessary.

Event Description

It was reported the magazine came out and was stuck in the peritoneum.During a laparoscopic radical (total) prostatectomy (lrp) procedure, while using the laparoscopic clip appliers it was reported the clip magazine "jumped" off and stuck to the patient's peritoneum causing bleeding.The surgeon was not able to visualize the magazine with the 0° (degree) optic scope, however, was able to see and retrieve the magazine with a 30° (degree) optic scope.The surgery was delayed approximately 45 minutes.No other information has been provided.Additional information has been requested, however, not yet received.Associated medwatches: 9610612-2019-00182 (handle); 9610612-2019-00184 (clip).

• 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8438250
• MDR Text Key: 139380386
• Report Number: 9610612-2019-00183
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL522R
• Device Catalogue Number: PL522R
• Device Lot Number: 62295653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/19/2019
• Device Age: 2 MO
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• 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
• Patient Outcome(s): Required Intervention