MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) SHEATH, INNER CFR, 22.5 FR.; INNER SHEATH

Model Number 8655.3441

Device Problem Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Facility notified (b)(4) on (b)(6) 2017 and relayed that during a case the beak broke off and no injuries had occurred.(b)(4) sales representative was contacted and indicated beak broke into pieces however they were retrieved and procedure completed as scheduled.The removal of the foreign objects cause a delay in the procedure that may have resulted in patient being at risk.(b)(4) also received a medwatch report ((b)(4)) on 04/10/2017, indicating that during a hysteroscopy procedure device broke inside of body cavity.No injuries to patient or staff were reported.No similar issues on this device in the last three years resulting in a medical device report.Manufacture date : 08/2012.Purchase date: (b)(6) 2013.User facility was contacted for missing and additional information on several occasions, no information received as of 04/20/2017.(b)(4).(b)(4) considers this report closed.If any additional information is received a follow up report will be sent.

• Brand Name: SHEATH, INNER CFR, 22.5 FR.
• Type of Device: INNER SHEATH
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6508219
• MDR Text Key: 73399119
• Report Number: 1418479-2017-00007
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207028087
• UDI-Public: 04055207028087
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2017,03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8655.3441
• Device Catalogue Number: 8655.3441
• Device Lot Number: 1186685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2017
• Distributor Facility Aware Date: 03/23/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OUTER SHEATH; ROTATABLE CONNECTOR