MAUDE Adverse Event Report: AESCULAP AG INSULATED OUTER TUBE 5/5MM 310MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PM973R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported to aesculap inc.That a finochietto-burford rib spreader (part # fb805r) was used during a surgery performed on (b)(6) 2021.According to the complainant, during the procedure, the tenaculum forceps d:5/310m completely broke while inside a patient while the surgeon was holding the uterus.Reportedly, the device did not fully shear off, but it did bend/shear at almost a 90 degree angle while inside the patient.The surgical staff had to stop what they were doing, remove the trocars, and work to get the instrument out of the patient.No other device was required to remove the broken forceps; the surgical staff was able to pull everything out slowly.There was a to 10 - 15 minute delay due to the intraoperative event.The device malfunction did not cause or contribute to a serious injury or death.This complaint involves one (1) device.The device is available for evaluation.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under (b)(4) reference (b)(4).
Event or Problem Description
An additional medical intervention was necessary.This event prolonged the surgery for 10-15 minutes.The adverse event is filed under aag reference xc 100027414; cc 400502022.Involved components: pm777r - jaw ins.Tenaculum forceps d:5/310mm - lot unknown po959r - monopolar handle with ratchet - lot unknown.
Additional Manufacturer Narrative
Additional information - a3, d10, f9, f10 corrected data - d1, d2, d4 (part #, udi) investigation results: visual investigation: the shaft is fractured near the distal end.Vigilance investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload, probably due to torsion and/or leverage during handling.No pores, inclusions or foreign bodies could be found on the point of rupture.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.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.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 a capa is not necessary.

• Brand Name: INSULATED OUTER TUBE 5/5MM 310MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11406223
• Report Number: 2916714-2021-00025
• Device Sequence Number: 14298355
• Product Code: GEI
• UDI-Device Identifier: 04038653183715
• UDI-Public: 4038653183715
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022
• Report Date (Section F): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM973R
• Device Catalogue Number: PM973R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2021
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PO777R - LOT # UNKNOWN; PO959R - LOT # UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/03/2021