MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING; PIN, FIXATION, SMOOTH

Catalog Number 0234102060

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: expired product was used.Probable root cause: design, validated shelf life too short, shelf life/expiration date not adequately published on package.Application: distribution inefficient, sat too long in inventory before being shipped to customer; user inattentive to expiration date of product.(b)(4).

Event Description

It was reported that an expired product was used.

• Brand Name: PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7112794
• MDR Text Key: 94949840
• Report Number: 0002936485-2017-01194
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

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: Health Professional
• Device Catalogue Number: 0234102060
• Device Lot Number: 15302AE2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1