MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.

Event Description

On september 29, olympus medical systems corp.(omsc) received the literature "snare-tip soft coagulation is effective and efficient as a first-line modality for treating intraprocedural bleeding during barrett¿s mucosectomy¿.The purpose of the literature was to evaluate the safety, efficacy, and efficiency of snare-tip soft coagulation (stsc) as a first-line modality for the treatment of intraprocedural bleeding (ipb) during multiband mucosectomy (mbm) for barrett¿s neoplasia.The multiband mucosectomy was performed using a high-definition diagnostic gastroscope (olympus) and a mbm duette apparatus (non-olympus).Persistent bleeding was treated with hemostatic forceps (olympus).In the literature, it was reported one patient of delayed bleeding required the transfusion and the hospitalization as below: ¿one episode of delayed bleeding occurred, within 24 hours, in a patient where hemostasis had been achieved with stsc for minor ipb.The patient was hospitalized, received a blood transfusion, and was successfully treated by repeat endoscopic intervention.¿ the other complications were also reported as below: ¿ipb occurred in 63 mbm procedures (21.6%; 95%ci 17.3%¿ 26.7%).Of these, 51 (81.0%) underwent stsc as first-line modality.Hemostasis was achieved in 48 cases, equating to 94.1% (95%ci 84.1%¿ 98.0%) and 76.2% by per-protocol and intention-to-treat analysis, respectively.Stsc was not attempted in the remaining 12 patients because of pooling of blood from multifocal bleeding points or occurrence of bleeding at the 9-o¿clock position with the patient in the left lateral position.Of these, 11 patients required hemostatic forceps to grasp and tent the bleeding point away from the pooled blood to allow electrosurgical current to flow to the site of bleeding.In one patient, a mechanical clip was used for unclear reasons.Two patients required adrenaline injection to localize the bleeding point prior to the use of hemostatic forceps.Of the ipbs, 13 were major (4.5%; 95% ci 2.6%¿ 17.3%), of which eight were treated with stsc.Hemostasis was achieved in 97.7% (95%ci 87.9%¿ 99.6%) and 75.0% (95%ci 40.9%¿ 92.9%) of minor and major ipbs treated by stsc, respectively.¿ based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, 1 case of a delayed bleeding might occur after the treatment of minor ipb using the olympus hemostatic forceps and the patient required the transfusion and the hospitalization.This is the report regarding 1 case of a delayed bleeding required the transfusion and the hospitalization.

• Type of Device: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 12545012
• MDR Text Key: 274520129
• Report Number: 8010047-2021-12426
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other