MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHEATH, STRYKEPROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0250070460
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that sheath broke inside patient.All pieces were retrieved from the patient.
Event or Problem Description
It was reported that sheath broke inside patient.All pieces were retrieved from the patient.
Additional Manufacturer Narrative
Alleged failure: the tip of the sheath was broken off into the patient body.The broken flakes were retrieved but they were not sure all the flakes had been retrieved completely.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or instrument got caught during retraction.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.Gtin: nr.

• Brand Name: SHEATH, STRYKEPROBE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9214837
• Report Number: 0002936485-2019-00471
• Device Sequence Number: 18966195
• Product Code: GEI
• UDI-Device Identifier: 07613327051971
• UDI-Public: 07613327051971
• Combination Product (Y/N): N
• PMA/510(K) Number: K963765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0250070460
• Device Lot Number: NR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1