| Brand Name | PKG. ASSY. SUCTION IRRIGATOR 2 |
|---|
| Common Device Name | Laparoscope, General & Plastic Surgery |
|---|
| 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 |
|
arsalan
rizvi
|
| 5900 optical court |
| san jose, CA 95138
|
|
+1(408)754-2000
|
|
|---|
| MDR Report Key | 50150032 |
|---|
| Report Number | 0002936485-2026-00561 |
|---|
| Device Sequence Number | 10603324 |
|---|
| Product Code |
GCJ
|
| UDI-Device Identifier | 37613327061391 |
|---|
| UDI-Public | 37613327061391 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter State | AZ |
|---|
| Initial Reporter Country | US |
|---|
| PMA/510(K) Number | Exempt |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
Other,Health Professional |
|---|
| Initial Reporter Occupation |
Other Health Care Professional
|
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
08/05/2026 |
|---|
| 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 | 0250070500 |
|---|
| Device Lot Number | PR4042537 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Initial Date Received by Manufacturer | 07/09/2026 |
|---|
| Initial Report FDA Received Date | 08/05/2026 |
|---|
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
|---|
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
Initial
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Sex | Unknown |
|---|
