MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG CURVED SCISSORS,PISTOL GRIP,5MM X 45CM; ULTRASONIC SURGICAL DEVICE

Model Number	T3795
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature: "fracture of a probe tip of the ultrasonic laparoscopic coagurating shears during laparoscopic uterine fibroid enucleation in which fallen debris was recovered -a case report".Literature summary: ultrasonic laparoscopic coagulating shears (lcs) are surgical instruments that can perform coagulation and incision at the same time by ultrasonic vibration and are often used in laparoscopic surgery.Since a large force is applied to the tip of the probe, the probe can break depending on the usage conditions.A 43-year-old woman underwent laparoscopic uterine myomectomy due to uterine fibroids.Lcs became an error mode at the time of making a longitudinal incision in the muscularis layer of the posterior wall of the uterus and became unusable.Fracture of the probe tip was confirmed.Although the part of the probe was searched in the surgical field and the extracorporeal area, it could not be found.It was eventually found by using an intraoperative x-ray and could be removed outside the body.Postoperative investigation pointed out a small damage that coincided with the fractured part.It might be the cause of the fracture.We present some precautions for using the lcs and those for collecting the fallen debris, with a review of the literature.Type of adverse events/number of patients: the tip of the probe partially broke off and fell out into the patient's abdominal cavity n=1.Since the literature described "sonosurg curve scissors (olympus medical systems)", we selected "sonosurg scissors t3795" as a representative product.
Additional Manufacturer Narrative
This supplement is being reported to correct the initial mfg report 9614641 - 2022 - 00024.It was submitted in error and identified as a duplicate report.The event was originally reported in december 2015 as mdr mfg report 8010047-2015-01325.

• Brand Name: SONOSURG CURVED SCISSORS,PISTOL GRIP,5MM X 45CM
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15086092
• Report Number: 9614641-2022-00024
• Device Sequence Number: 5102105
• Product Code: LFL
• UDI-Device Identifier: 04953170235641
• UDI-Public: 04953170235641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: T3795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 43 YR
• Patient Sex: Female