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

Model Number	FG-401Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code - appropriate term/code not available for cholecystitis and hepatic portal venous gas.To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled, "a case of hepatic portal venous gas due to ercp".Literature summary: a 93-year-old man was diagnosed with acute obstructive cholangitis due to choledocholithiasis.Endoscopic papillary balloon dilatation was performed after endoscopic retrograde cholangiopancreatography (ercp).At the time of endoscopic bile duct stone removal, the basket catheter might have injured the cystic duct.The patient experienced epigastric pain 4 hours after ercp.The following morning, a computed tomography (ct) scan showed air in the cystic duct and the portal branches of the right hepatic lobe.The patient was diagnosed with hepatic portal venous gas (hpvg) and cholecystitis due to obstruction of the bile duct caused by suspected damage to the bile duct.An enhanced ct 1 hour later showed no signs of intestinal necrosis, and the portal venous gas decreased.Consequently, conservative treatment was performed for hpvg and percutaneous transhepatic gallbladder drainage was performed for cholecystitis.Pathological examination revealed evidence of chronic cholecystitis and an area of mucosal defect in a part of the bile duct.The inflammatory cell infiltration in this area was less than that in the surrounding area, suggesting the possibility of mechanical injury, but unable to identify the site of injury caused by the basket manipulation.Conclusion: a follow-up ct 24 hours later showed marked resolution of the hpvg, and the patient recovered well.Although hpvg is the rarest complication of ercp, it should be considered when the patient experiences post-procedural abdominal pain.Type of adverse events: ·hepatic portal venous gas (hpvg) with abdominal pain; ·cholecystitis; ·slight bleeding.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the investigation.A definitive root cause could not be determined.Based on the available information, it was determined that a device malfunction was not reported and the reported event was likely not caused by a device malfunction.
Event or Problem Description
Olympus further received information that confirmed there is no relationship between olympus devices and bleeding.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information obtained from the author.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.   since the actual product was not sent, 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.   olympus will continue to monitor field performance for this device.  updated fields: b5: updated to reflect the additional information received.H6: type of investigation: device not returned.Investigation findings: no device problem found.

• Brand Name: DISPOSABLE GRASPING FORCEPS
• Common Device Name: DISPOSABLE 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: 16524603
• Report Number: 9614641-2023-00362
• Device Sequence Number: 2316290
• Product Code: OCZ
• UDI-Device Identifier: 04953170160929
• UDI-Public: 04953170160929
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: FG-401Q
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 04/06/2023; 04/06/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/05/2023; 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male