MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LAP.APPLIER ML 10/310MM; LIGATION / VESSEL CLIPS

Model Number PL807R

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2019

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 issue with the clip applier instrument.During an unspecified surgery, the applier did not release the clip correctly.Additional information was not provided.

Manufacturer Narrative

G1/2: contact information updated due to expiration of exemption e2014018.Manufacturing site evaluation: investigation: both applier components were returned in used condition.The box lock screw is missing from one applier.During functional testing with a clip magazine and trial vessel material, the reported deviation could not be duplicated.The mouth parts show signs of usage, but no deviation.Additionally, analysis of instruments in the manufacturing plant did not show any deviation either.Batch history review: the device quality and manufacturing records could not be reviewed as the lot number is unknown.Conclusion and root cause: based on the information available, it is not possible to determine a definitive root cause.It could be possible that the failure is usage related.No manufacturing relationship is established.Rationale: the applicator does not show any deviation.Based on the results of our investigation, including attempts to duplicate the reported failure, it seems most probable that the difficulty encountered is usage related.Corrective action: no trend for reports of this type is established.According to sa-de13-m-4-2-04-000-0 there is no capa necessary.

• Brand Name: DS-SINGLE FIRE LAP.APPLIER ML 10/310MM
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8685099
• MDR Text Key: 147598203
• Report Number: 9610612-2019-00374
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL807R
• Device Catalogue Number: PL807R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Distributor Facility Aware Date: 05/29/2019
• Device Age: 46 MO
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1