MAUDE Adverse Event Report: AESCULAP AG NEEDLE HOLDERSTRAIGHT 5MM 370MM; REUSABLE INSTRUMENTS

Model Number PL404R

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that there was an issue with pl404r - needle holder straight 5 mm 370 mm.According to the complainant, two needle holders "broke again" this week.The previously reported complaint had noted "not grasping" as the failure mode.Patient harm was unknown.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) (9610612-2022-00297) pl404r and (b)(4) (9610612-2022-00298) pl404r.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

Update: patient harm changed to no patient hazard.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) (9610612-2022-00297) pl404r.(b)(4) (9610612-2022-00298) pl404r.

Manufacturer Narrative

Additional information/correction: b5-patient harm.D9-date returned to manufacturer.H3-device evaluation.H6-codes.After review of the investigation and harm, the complaint was re-assessed and determined to no longer be reportable.Investigation results: visual investigation: an interlock function test was positive - function is given.The interlock shows extreme signs of wear.Looking into the handle at the mechanism, there are a lot of rust spots.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.The review of risk assessment revealed that the overall risk level (severity 1(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale the error patterns with the extreme wear on the locking mechanism with chip abrasion as well as the rust traces in the handle on the mechanism are in all probability clear indications of a lack of maintenance in the form of oiling after reconditioning.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably maintenance-related.Based upon the investigations results a capa is not necessary.

• Brand Name: NEEDLE HOLDERSTRAIGHT 5MM 370MM
• Type of Device: REUSABLE INSTRUMENTS
• 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: 15562663
• MDR Text Key: 302287867
• Report Number: 9610612-2022-00297
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL404R
• Device Catalogue Number: PL404R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/28/2022
• 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