MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR 12 AND 30 TELESCOPE

Model Number	A20718A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined at this time.As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The instruction manual warns users ¿before use - operate the handle.Make sure that the jaws open and close smoothly.¿ in addition, the original equipment manufacturer (oem) performed a manufacturing and quality control review for the last 24 months of production and found no non-conformities or deviations related to the reported issue.A review of the device history record could not be performed as the reporter provided an incorrect serial/ lot number.In an effort to mitigate this type of forcep malfunction the oem recommends that the stone punch be used to crush stones and not the a20718a that is intended for grasping objects in the bladder like ureteral stents, not for crushing stones.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the forceps became locked in the open position and damaged the patient¿s urethra.It is unknown if the intended procedure was completed or if the patient was treated.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.The customer¿s complaint was confirmed.A visual inspection was performed on the returned device and found the device handle loose.The manipulation pin was noted to be bent at the distal end causing the jaws to not open and close properly.There were also deep scratches noted inside the inner sheath near the bent manipulation pin.Based on the evaluation, the cause of the bent manipulation pin and deep scratches on the inner sheath can be attributed to mishandling.The cause of the loose handle is due to excessive stress and force.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR 12 AND 30 TELESCOPE
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8034930
• Report Number: 2951238-2018-00670
• Device Sequence Number: 1584888
• Product Code: GCP
• UDI-Device Identifier: 04042761029889
• UDI-Public: 04042761029889
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A20718A
• Device Catalogue Number: A20718A
• Device Lot Number: 183W-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other