MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:10MM L:260MM; HANDHELD PRODUCTS & LIGATION

Model Number PL538R

Device Problem Unintended Ejection (1234)

Patient Problem Lethargy (2560)

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual investigation: the complaint samples were provided in a decontaminated, used condition.The following components were provided for investigation: 2 x pl538r x shaft (400582174 & 400582175).2 x pl510r x handle (400582172 & 400582173).The complaint sample for the clip cartridge (1 x pl579t - 400578391) was not provided for investigation, thus a failure description for this product is not possible.Both shafts were found to be slightly bent during visual inspection, which was possibly caused by improper handling during reprocessing.Dimensional inspection revealed that the magazine retention force is not according to specification for both shafts.This deviation is a likely result of the shafts being slightly bent.For shaft pl538r - cc400582174 it was also found that the maintenance date was neglected.The shaft was supposed to be sent in for maintenance latest until september 2016.Further, the jaw width was found to be out of specification.The inspection of the provided handles (2 x pl510r; 400582172; 400582173) did not reveal any deviation.Batch history review: due to the fact that no lot number was provided for the leading material, a review of the device history records as well as a batch-related complaint history review is not possible.The device quality and manufacturing history records (dhr) for the involved material have been checked for the provided lot number (62324280 / cc- 400582173).The products were found to be according to our specification valid at the time of production.No similar complaint could be identified for the reported batch number.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability 1(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: based upon the investigation results, a definitive root cause could not be established.It cannot be ruled out that a usage-related failure led to the reported issue.The returned shafts are no longer according to specification.On one shaft the recommended maintenance date was neglected.According to the applicable ifu, the recommended maintenance date shall be observed to ensure reliable operation.In general when cutting clipped structures in order to avoid the dislocation of clips, it shall be observed to not cut too close to the clip and also to leave an area of tissue of at least the width of double the clip between the clip and cutting site.It shall also be observed to ensure that the structure is not under tension when cutting.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Event Description

It was reported that there was an issue with pl538r - shaft compl.D:10mm l:260mm.According to the complaint description, the clips did not hold and fell off a cleanly clipped cystic stump (2x).The patient was then surgically revised, required endoscopic retrograde cholangiopancreatography (ercp), and subsequently percutaneous drainage (for persistent collection).Postoperatively, the patient was transferred to another unit and has not fully recovered 1 month after surgery (increased fatigue, poor appetite).A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00360 (400578391 - pl569t); 9610612-2023-00156 (400582174 - pl538r).Involved components: pl510r - handle f/pl506r & pl508r - lot unknown; pl510r - handle f/pl506r & pl508r - lot 62324280; pl569t - ligating clips m/l 12/box - lot unknown.

• Brand Name: SHAFT COMPL.D:10MM L:260MM
• Type of Device: HANDHELD PRODUCTS & LIGATION
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17140255
• MDR Text Key: 317299669
• Report Number: 9610612-2023-00157
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL538R
• Device Catalogue Number: PL538R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PL510R - LOT 62324280.; PL510R - LOT UNKNOWN.; PL569T - LOT UNKNOWN.
• Patient Outcome(s): Required Intervention