MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., SINGLE SPIKE TUBE SET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0250070530
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that foreign materials were found inside the sterile package.
Additional Manufacturer Narrative
Alleged failure: it was reported that adhesive residue was noted at different points on the tubing after the product was opened, before it was dispensed onto the sterile field.Ahs mdip reference number (id): (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be manufacturing process.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that foreign materials were found inside the sterile package.

• Brand Name: PKG., SINGLE SPIKE TUBE SET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9611766
• Report Number: 0002936485-2020-00041
• Device Sequence Number: 353355
• Product Code: GEI
• UDI-Device Identifier: 37613327061353
• UDI-Public: 37613327061353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: Other
• Device Catalogue Number: 0250070530
• Device Lot Number: 19157FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1