MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) INNER SHEATH

Model Number	8655.384
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf medical instruments cooperation (rwmic) was informed by one of its sales representatives that during a procedure the device in question broke off inside of patient.Procedure completed as scheduled.No injury to patient or staff reported.Device approximately (b)(4) years old.Facility has been contacted, via phone and email, in an effort to gather additional/missing for medwatch report.No response received as of (b)(6) 2017.There have been two similar complaints have been reported last three years (mdr 1418479-2015-0027 and 1418479-2015-00029).Instructions for use (ifu) contains the following: 7 use caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.7.2.5 hf application warning! activate hf instruments only after the live part conducting hf current has become fully visible in the field of view of the endoscope and touches the intended area to be treated.8.1 checks caution! be careful if products are damaged or incomplete.Injuries of the patient, user or others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Device has not been returned.If rwmic receives device, it will be sent to manufacturer for investigation.Rwmic considers this report closed.If rwmic receives additional information regarding this incident, a follow up report will be sent to the fda.

• Brand Name: INNER SHEATH
• Common Device Name: SHEATH
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6935719
• Report Number: 1418479-2017-00028
• Device Sequence Number: 13650079
• Product Code: FDC
• UDI-Device Identifier: 04055207059708
• UDI-Public: 04055207059708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2017
• Report Date (Section F): 10/10/2017

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: Physician
• Device Model Number: 8655.384
• Device Catalogue Number: 8655.384
• Device Lot Number: 1208503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2017
• 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
• Date Report Sent to FDA: 10/10/2017