MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted report adverse events and to provide investigation results no physical evaluation/inspection could be conducted on the suspect device as it was not returned to olympus.The device history record (dhr) for the complaint device could not be reviewed since the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.There was no report of olympus device malfunction and no information connecting the cause of the reported events to the device.For these reasons, the definitive cause of the reported events could not be determined.

Event Description

It is reported in the literature titled: ¿short- and long-term outcomes after minimally invasive versus open spleen saving distal pancreatectomies,¿ patients experienced adverse events after procedures using an olympus thunderbeat device.Study background/aim: this study aimed to compare the perioperative outcomes of patients who underwent minimally invasive spleen-preserving distal pancreatectomy (mi-spdp) versus open surgery spdp (o-spdp).It also aimed to determine the long-term vascular patency after spleen-saving vessel-preserving distal pancreatectomies (ssvdps).Method: a retrospective review of 74 patients who underwent successful spdp and met the study criteria was performed.Of these, 67 (90.5%) patients underwent ssvdp, of which 38 patients (21 open, 17 mis) had adequate long-term post-operative follow-up imaging to determine vascular patency.Results: fifty-one patients underwent open spdp, whereas 23 patients underwent minimally invasive spdp, out of which 10 (43.5%) were laparoscopic and 13 (56.5%) were robotic.Patients who underwent mi-spdp had significantly longer operative time (307.5 vs.162.5 min, p = 0.001) but shorter hospital stay (5 vs.7 days, p = 0.021) and lower median blood loss (100 vs.200 cc, p = 0.046) compared to that of o-spdp.Minimally invasive spleen-saving vessel-preserving distal pancreatectomy (mi-ssvdp) was associated with poorer long-term splenic vein patency rates compared to o-ssvdp (p = 0.048).This was particularly with respect to partial occlusion of the splenic vein, and there was no significant difference between the complete splenic vein occlusion rates between the mis group and open group (29.4% vs.28.6%, p = 0.954).The operative time was statistically significantly longer in patients who underwent robotic surgery versus laparoscopic surgery (330 vs.173 min, p = 0.008).Conclusion: adoption of mi-spleen-preserving distal pancreatectomy (spdp) is safe and feasible.Mi-spdp is associated with a shorter hospital stay, lower blood loss but longer operation time compared to o-spdp.In the present study, mi-ssvdp was associated with poorer long-term splenic vein patency rates compared to o-ssvdp.In this study, it was found that patients who underwent mis surgery had a significantly shorter hospital stay and decreased blood loss but at the expense of a longer operative time compared to that of open surgery.There was also a higher frequency with the use of the warshaw technique with mis surgery, in particular via conventional laparoscopy.There was no difference in post-operative morbidity or mortality between both procedures.We also found that there were no significant differences in long-term splenic artery patency rates and splenic perfusion between the open and mis groups.There is no report of olympus device malfunction described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14208857
• MDR Text Key: 290084234
• Report Number: 8010047-2022-07035
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other