MAUDE Adverse Event Report: AESCULAP AG TREPANBOGEN HUDSON; INSTRUMENTS FOR NEUROSURGERY

Model Number FF056R

Device Problems Failure to Cycle (1142); Device-Device Incompatibility (2919)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a trepanbogen hudson (part # ff056r) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the glove was caught in the gap of the device handle and subsequently tore.Reportedly, the glove tore twice.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visually, no deviation could be found at the provided device.Investigation was carried out by the q-coordinator of the production plant in charge.Excerpt of the investigation report: when checking item ff056r, the tolerance 0.15 mm (on both sides) on the crank handle was checked with a feeler gauge.If the crank handle is pressed on one side, 0.15 mm of feeler gauge goes straight into the gap that is present for the play.Conversely, this means that the specification has been met.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There is one similar complaint against the same lot number(s); similar complaint from same customer.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the investigation report of the responsible q-coordinator, the product is according to the specifications valid at the time of production.Conclusion and measures / preventive measures: based upon the investigation results, a clear root cause conclusion cannot be determined.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: TREPANBOGEN HUDSON
• Type of Device: INSTRUMENTS FOR NEUROSURGERY
• 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: 12924229
• MDR Text Key: 283173384
• Report Number: 9610612-2021-00766
• Device Sequence Number: 1
• Product Code: HXY
• UDI-Device Identifier: 04038653162949
• UDI-Public: 4038653162949
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF056R
• Device Catalogue Number: FF056R
• Device Lot Number: 52602570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• 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 Sex: Male