MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number KD-620LR

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

Patient Problem Peritonitis (2252)

Event Date 01/24/2022

Event Type  Injury  

Event Description

[it is reported in the literature titled ¿feasibility of transgastric endoscopic gallbladder preserving surgery for benign gallbladder diseases,¿ four patients experienced localized peritonitis after procedures using multiple olympus devices.Case with patient identifier (b)(6) reports /localized peritonitis/gif-q260j/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis /d-201-11802/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis kd-620lr/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis /kd-611l/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis /hx-600-135/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis /maj-339/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis /sd-230u-20/female 48years.Case with patient identifier (b)(6) reports /localized peritonitis gif-q260j/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /d-201-11802/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /kd-620lr/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /kd-611l/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /hx-600-135/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /maj-339/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /sd-230u-20/female 52years.Case with patient identifier (b)(6) reports /localized peritonitis /gif-q260j/male 34years.Case with patient identifier (b)(6) reports /localized peritonitis /d-201-11802/male 34years.Case with patient identifier (b)(6) reports /localized peritonitis /kd-620lr/male 34years.Case with patient identifier (b)(6) reports /localized peritonitis /kd-611l/male 34years.Case with patient identifier (b)(6) reports /localized peritonitis /hx-600-135/male 34years.Case with patient identifier (b)(6) reports /localized peritonitis /maj-339/male 34years.Case with patient identifier (b)(6) reports /localized peritonitis /gif-q260j/female 60years.Case with patient identifier (b)(6) reports /localized peritonitis /d-201-11802/female 60years.Case with patient identifier (b)(6) reports /localized peritonitis /kd-620lr/female 60years.Case with patient identifier (b)(6) reports /localized peritonitis /female 60years.Case with patient identifier (b)(6) reports /localized peritonitis /hx-600-135/female 60years.Case with patient identifier (b)(6) reports /localized peritonitis /maj-339/female 60years.Background: with the increasing realization of the importance of gallbladder function, choledochoscopic gallbladder-preserving surgery has been advocated for benign gallbladder diseases.However, limited information is available regarding the use of endoscopic gallbladder-preserving surgery (egps) for patients with benign gallbladder diseases.The aim of this study was to evaluate the feasibility of egps for benign gallbladder diseases.Methods: between june 2020 and january 2021, 22 patients with gallbladder stones and/or gallbladder polyps were treated with egps.The main outcome measures included the rate of complications, residual gallbladder stones, and gallbladder stone recurrence.Results: in this study, transgastric egps was successfully performed in 22 patients (13 female, 9 male) with benign gallbladder diseases, and included 8 cases of multiple gallstones, 4 cases of gallbladder polyps with gallstones, 6 cases of multiple gallbladder polyps, 2 cases of single gallstone, and 2 case of singe gallbladder polyp.The median time of transgastric egps was 118 min.During hospitalization, 4 patients suffered localized peritonitis (4/22, 18.2%), and these patients successfully recovered after conservative medical treatment.None of the patients experienced massive bleeding, delayed bleeding, diffuse peritonitis, or any other serious complications.During the median follow-up of 4 months, 1 patient suffered residual gallstone, while no gallstone recurrence or deaths related to transgastric egps occurred in any patients.Conclusions: transgastric egps appears to be a feasible treatment method in selected patients with benign gallbladder diseases.However, as it is a new technique, further studies are needed to explore the long-term effectiveness of transgastric egps.There is no report of olympus device malfunction reported in any procedure described in this study.

Manufacturer Narrative

This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Manufacturer Narrative

This report is being supplemented to provide additional information added to b3, d8 and h6.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; tokyo-to, hachioji-shi 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: 15084454
• MDR Text Key: 296404402
• Report Number: 8010047-2022-12086
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• 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
• Date Manufacturer Received: 08/02/2022
• 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): Required Intervention; Other; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male