MAUDE Adverse Event Report: AESCULAP AG DUROGRIP NEEDLE HOLDER STR.D:5/310MM; NEEDLEHOLDERS (LAPAROSCOPIC SU)

Model Number PL407R

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.The tip of the locking mechanism is worn.A functional test could only be carried out after lubricating the moveable part of the device accordingly.Due to the worn tip, the locking mechanism no longer engages.According to the ifu, the lubrication must be sufficiently to avoid a damage to the mechanism.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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 x probability of occurrence) according to din en iso 14971 is still acceptable.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.Based upon the investigations results there is capa is not necessary.

Event Description

It was reported that there was an issue with pl407r - durogrip needle holder str.D:5/310mm.According to the complaint description, the laparoscopic needleholder, purchased a few weeks ago, has failed on it's first use.There was no described patient harm.This malfunction prolonged the surgery for 5 minutes.Additional information was not provided was not available.Additional patient information is not available.The adverse malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: DUROGRIP NEEDLE HOLDER STR.D:5/310MM
• Type of Device: NEEDLEHOLDERS (LAPAROSCOPIC SU)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11437016
• MDR Text Key: 241400059
• Report Number: 9610612-2021-00108
• Device Sequence Number: 1
• Product Code: HXK
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL407R
• Device Catalogue Number: PL407R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1