MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. GRASPING FORCEPS

Model Number FG-48L-1

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/02/2009

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "usefulness of a second endoscopic arm to improve therapeutic endoscopy in the lower gastrointestinal tract.Preliminary experience ¿ a case series".The aim of our study was to test the feasibility of utilizing a second endoscopic arm to exert counter-traction to lift the lesion away from the cutting plane, ameliorating submucosal exposure.Total eight patients were included in this study.Three complications occurred and were managed endoscopically.One patient experienced a small perforation in the sigmoid colon.Two patients presented with delayed bleeding.Applying counter-traction with a second endoscopic arm can facilitate submucosal dissection of distal colorectal lesions.Type of adverse events/number of patients.Perforation - 1 patient.Delayed bleeding - 2 patients.This literature article requires 9 reports.The related patient identifiers are as follows: (b)(6) for fg-48l-1, pt #4: perforation.(b)(6) for cf-q165i, pt #4: perforation.(b)(6) for fg-46u-1, pt #4: perforation.(b)(6) for fg-48l-1, pt #5: delayed bleeding.(b)(6) for cf-q165i, pt #5: delayed bleeding.(b)(6) for fg-46u-1, pt #5: delayed bleeding.(b)(6) for fg-48l-1, pt.#7: delayed bleeding.(b)(6) for cf-q165i, pt.#7: delayed bleeding.(b)(6) for fg-46u-1, pt.#7: delayed bleeding.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

The authors report gf um160 was used to detect infiltration of the muscularis propria and/or the presence of perivisceral lymph nodes at preliminary endoscopic ultrasound which contraindicated endoscopic treatment and therefore excluded from the study.Xst-28ch-m is prototype device not cleared for market.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 Description

The following additional information was received from the physician: ¿the adverse events described in the article are attributable neither to the olympus instrumentation nor to its malfunctioning, but rather to the method of submucosal dissection itself which, as is well known from the literature, is an invasive technique and subject to complications such as those described in the article.¿.

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 olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING 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: 15802355
• MDR Text Key: 303720074
• Report Number: 9614641-2022-00627
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04953170032387
• UDI-Public: 04953170032387
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K955051
• 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
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-48L-1
• 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: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NON-OLYMPUS, ROTH NET RETRIEVAL NET, SN UNKNOWN.; OLYMPUS, CF-Q165I, SN UNKNOWN.; OLYMPUS, FG-46U-1 , LOT UNKNOWN.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female