MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, J TIP, 5MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070442
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: sheath melted.Probable root cause: material/design error, manufacturing/assembly error, excessive user force, severe shipping conditions, disposable tip rubbing against product, user error.The device manufacture date is not known.
Event or Problem Description
It was reported that the sheath broke during a procedure and cannot be confirmed that all pieces were retrieved.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: sheath melted.Probable root cause: 1.Material/design error 2.Manufacturing/assembly/ service error 3.Excessive user force 4.Severe shipping conditions 5.Disposable tip rubbing against product 6.User error the device manufacturer date is not known.
Event or Problem Description
It was reported that the sheath broke during a procedure and cannot be confirmed that all pieces were retrieved.

• Brand Name: PKG, STRYKERFLOW ELECTROCAUTERY PROBE, J TIP, 5MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8177055
• Report Number: 0002936485-2018-00721
• Device Sequence Number: 11096053
• Product Code: GCJ
• UDI-Device Identifier: 07613327051889
• UDI-Public: 07613327051889
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K934094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: 0250070442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 06/20/2019
• 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
• Patient Age: 59 YR
• Patient Weight: 80