MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number FD-412LR

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

Patient Problem Bacterial Infection (1735)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

F23015082-1 : tier 1 universal failure code: etz capa? no.Mail:(b)(4).[answer category].Summary final answer: survey level: tier 1: universal failure code: etz (because there is no indication for the actual product).Survey results: since the actual product was not sent, we could not confirm the event you pointed out.However, since the literature did not describe any defects related to the product, it is considered that this event was not caused by the defect of the product.Cause: from the content raised (reported), it is presumed that it was not caused by a defect in the product, but the cause could not be identified.Capa history review: there were no open capa or closed capa in the past three years for this event.Complaint review: there were no compliant events at the same facility and on the same equipment that were the same as or similar to the reported event.Review of manufacturing records: since the lot/serial number was unknown, the manufacturing history record could not be reviewed.However, omsc only shipped devices which passed the inspection.Whether the equipment conformed to the specifications (at the time of the actual product survey) (in the case of pae projects): not applicable because the actual product will not be sent.Whether the device was used for treatment / diagnosis (at the time of pae case occurrence) (in the case of pae case): not applicable because there is no indication for the actual product.Relationship between equipment and adverse events / health hazards (in the case of pae projects): not applicable because there is no indication for the actual product.Actual product treatment judgment: not applicable because the actual product will not be sent.Actual product treatment method (reason for judgment): not applicable because the actual product will not be sent.Comments to the originator / customer: contact information for inquiries: if you have any questions about the survey results, please contact the following.Market qa2 complaint handling 3 sato.Mail: (b)(4).F23015082-2 : clinical / medical evaluation results.According to the definition in ombs w_8.2.2_01_002 complaint investigation work instruction, the complaint is determined as tier 1.Clinical / medical evaluation and risk assessment review is not required as bellow.Event 1:perforations - (40).The reporting event is an event listed in the harm list for which risk assessment was implemented and does not need to modify, so additional evaluation is not required in this case.Event 2:blood cultures cultured bacteria - (6).The reporting event is an event listed in the harm list for which risk assessment was implemented and does not need to modify, so additional evaluation is not required in this case.Event 3:fever - (15).The reporting event is an event listed in the harm list for which risk assessment was implemented and does not need to modify, so additional evaluation is not required in this case.Risk assessment review: an additional risk assessment is not required because it is a risk assessment already described in the clinical/medical evaluation.Conclusion: it is not possible to identify the root cause of the reported event.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is presumed that the reported event is an accident or a complication associated with a surgical procedure using the subject device.It took 2 years, 4 months and 10 days from the published date to the aware date.It was found a document due to a search for china pms.Investigation date: 2023/02/03.Investigator: (b)(4).F23015082-3 : conclusion.Event 1:perforations - (40) (tier 1).Event 2:blood cultures cultured bacteria - (6) (tier 1).Event 3:fever - (15) (tier 1).Since the actual product was not sent, we were unable to confirm the phenomenon you pointed out.However, since there was no mention of a product-related defect in the literature, we believe that this event was not caused by a defect in the product.Consideration: event 1:perforations - (40) (tier 1).Based on what has been raised (reported), we presume that it was not caused by a product defect, but we were unable to identify the cause.Event 2:blood cultures cultured bacteria - (6) (tier 1).Based on what has been raised (reported), we presume that it was not caused by a product defect, but we were unable to identify the cause.Event 3:fever - (15) (tier 1).Based on what has been raised (reported), we presume that it was not caused by a product defect, but we were unable to identify the cause.Related complaint: (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (other adverse event); (b)(6): fd-412lr (other adverse event).Investigation result: actual device confirmation result : not applicable because the actual device was not sent.Procedural purpose: not applicable as there are no indications for the actual device.Device record review: repair history; labeling; dhr; dmr; dhf.Since the lot number/manufacturing number of the device used is unknown, the manufacturing records cannot be investigated, but olympus conducts inspections and only ships products that pass the inspections.Complaint review.There were no complaints of events identical or similar to those reported at the same facility and on the same device.Capa history review: there were no capas in current open, or closed in the last three years for this event.Evaluation of combined device: as for the combination device, the actual device was not sent, and there was no description of any defects related to the device in the literature.Survey summary: product analysis: refer to the item ¿results of product confirmation¿ in the survey results.Labeling review: see the ¿labeling¿ section of the survey results.Dhr: see the ¿dhr¿ item in the survey results.Presumed cause: see the ¿discussion¿ section of the survey results.Risk analysis: conducted separately.Examination of the necessity of correction and corrective action: correction: refer to etq's correction column.Corrective action: see etq corrective action column.Quality data analysis and monitoring.Conducted with data analysis by ombs_8.4.0_01_001.Actual device treatment: not applicable because the actual device is not sent.Answer classification: final answer.Close the investigation based on the information gathered at this time.

Event Description

Olympus reviewed the following literature titled "prophylactic antibiotics may be unnecessary in gastric endoscopic submucosal dissection due to the low incidence of bacteremia." background and aims endoscopic submucosal dissection (esd) was developed as a feasible and reliable treatment for gastrointestinal mucosal or submucosal lesions.Bacteremia may occur after esd.Currently, the use of prophylactic antibiotics after gastric esd is controversial.This study was designed to explore the value of prophylactic antibiotics in the treatment of gastric mucosal and submucosal lesions after esd.Methods in this prospective study, in total, 103 patients who underwent gastric esd were included, and the frequency of bacteremia and changes in inflammation-related indicators before and after the procedure were investigated.The patients did not receive prophylactic antibiotics.Results the body temperature (t), white blood cell count (wbc), and procalcitonin (pct) and c-reactive protein (crp) levels did not significantly differ between the perforation group (n=40) and nonperforation group before gastric esd (n=63) (all p>0.05).The t, wbc, and crp levels (all p<0.05) in the patients with perforation were significantly higher than those in the patients without perforation 24 h after gastric esd.The incidence of bacteremia did not significantly differ between the two groups (all p>0.05).In total, 6 of 309 blood cultures were cultured with bacteria.The total frequency of bacteremia in the perforation and nonperforation groups was 2.5% and 3.2%, respectively.No sepsis occurred in any patients.Conclusion: regardless of whether perforation occurred after gastric esd, the incidence of bacteremia was transient and low.Therefore, based on our single-center study in china, prophylactic antibiotics may not be necessary in patients with intraoperative perforation during gastric esd.Type of adverse events/number of patients: perforations - 40 patients; blood cultures cultured bacteria - 6 cultures; fever - 15 patients.This literature article requires 14 reports.The related patient identifiers are as follows: for 6 patients with bacterial growth and other adverse events: (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (patient no.(b)(6)); (b)(6): fd-412lr (patient no.(b)(6)); (b)(6): kd-620lr (other adverse event); (b)(6): fd-412lr (other adverse event).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to h6 code (type of investigation) from previous submission.Code 3331 was inadvertently added; however, this code has been corrected to code 4111 instead.

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 serial and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes a correction to d4 (udi) and e4.Information added that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Type of Device: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16326546
• MDR Text Key: 309075578
• Report Number: 9614641-2023-00180
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170359804
• UDI-Public: 04953170359804
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

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: FD-412LR
• 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: 01/09/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 02/21/2023
• Supplement Dates FDA Received: 02/21/2023; 02/21/2023
• 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