MAUDE Adverse Event Report: AESCULAP AG FINOCHIETTO-BURFORD RIB SPREADRCOMPLETE; RETRACTOR

Model Number FB805R

Device Problem Mechanical Jam (2983)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Adverse event was reported to manufacturer using medwatch report number (2200350000-2020-8007).

Event Description

It was reported to aesculap inc.That a finochietto-burford rib spreader (part # (b)(4)) was used during a thoracic surgery performed in (b)(6) 2020.According to the complainant, during the procedure, the surgeon was unable to open or close the chest retractor after it was placed inside the patient.Reportedly, the patient experienced a major bleed of the pulmonary artery, and because the device was not able to be opened, the surgeon was not able to fully access the bleed site to sew the wound.After approximately fifteen (15) minutes of struggling with the device, it was able to be freed and removed.The surgeon was then able to address the bleed and successfully complete the procedure.The complaint device was returned to the manufacturer for evaluation.Additionally, the device was noted as being approximately two (2) years old.The patient's condition was noted as being "fine" at the conclusion of the procedure.Additionally, the reporter confirmed that the patient was stable post operatively.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the instrument provided is in a used condition.Friction marks can be found at the gliding surfaces caused by insufficient reprocessing.Due to this damages, a proper function of the instruments are no longer given.To avoid metal-on-metal friction instructions for reprocessing must be observed.This is also labelled on the instrument directly.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.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 of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results root cause was found to be insufficient reprocessing.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

No changes necessary.

• Brand Name: FINOCHIETTO-BURFORD RIB SPREADRCOMPLETE
• Type of Device: RETRACTOR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11317958
• MDR Text Key: 233017159
• Report Number: 2916714-2021-00017
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 04038653157945
• UDI-Public: 4038653157945
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2021,03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB805R
• Device Catalogue Number: FB805R
• Device Lot Number: 52477406_1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2021
• Distributor Facility Aware Date: 01/15/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White