MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP CABLE W/IRR GRAVITY, UNI; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6790100002
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during unboxing the device sterile packaging was found to be unsealed, posing the risk of exposure to excessive pathogens.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported that during unboxing the device sterile packaging was found to be unsealed, posing the risk of exposure to excessive pathogens.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: DISP CABLE W/IRR GRAVITY, UNI
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8226334
• Report Number: 0001811755-2019-00048
• Device Sequence Number: 19332253
• Product Code: GEI
• UDI-Device Identifier: 37613327304252
• UDI-Public: 37613327304252
• Combination Product (Y/N): N
• PMA/510(K) Number: K172367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 6790100002
• Device Lot Number: 5235301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1